What does this message actually mean, and what should I write down?
Your lamp has a session counter your prescriber controls, and this message means the prescribed sessions are used up or an authorization has expired. Before you call anyone, write down the exact model, serial number, and the message word for word. Evidence Evidence This statement has a dated source and is waiting for a clinician's sign-off. Pending clinical review
- Exact model and item number
- Serial number
- The message, word for word
- The date and count of your last session
How to use this step
- Limited evidence
Authorization and counter workflows are manufacturer- and model-specific, so your exact device’s current manual is the guide that applies, not a similar-sounding product. Keeping this record is what makes a second call fast if the first one does not resolve it, the same reason it is worth recording any treatment change.
Check before moving on
- Depends on you
A similar product name does not prove that the same message or process applies to your unit.
Check the FDA recall register yourself
I want you to check the FDA device recall register yourself, not only the manufacturer. FDA files these records under the firm’s legal name, not the brand printed on your lamp. Searched that way on 22 August 2026, it returned six Class II records with an ongoing status for the firm that makes these units. They cover several phototherapy models and the ClearLink control system software. Evidence Evidence This statement has a dated source and is waiting for a clinician's sign-off. Pending clinical review
How to use this step
- Limited evidence
FDA spells the product line two different ways across those records, so searching only the name on your unit can return none of them. Two of the six describe a software fault on resuming an interrupted treatment, which FDA’s own record ties to over- or under-dosing.
Check before moving on
- Depends on you
Whether any record covers your exact unit depends on the serial number, item number, software version, and dates inside that record, and only the live register settles it. A recall record does not explain a refill or authorization message on its own, and it does not say your device is unsafe. It does not decide whether to pause or continue. That is your prescriber’s call.
Who do I call, and in what order?
Call your prescribing office first, then the exact manufacturer route named in your manual. Phothera’s own patient FAQ tells people to contact their prescriber’s office when a unit says authorization is needed. Evidence Evidence Evidence This statement has a dated source and is waiting for a clinician's sign-off. Pending clinical review
- Have ready for manufacturer support: exact model and item number
- Serial number
- Software version on your unit, if the screen shows one
- The message, word for word
- Whether the FDA register lists your serial number or software version
How to use this step
- Limited evidence
Your prescriber and the manufacturer may need to coordinate, but neither replaces the other, and they are not the only routes. FDA MedWatch takes reports from patients about a device problem separately from the company that made it.
Check before moving on
- Depends on you
That Phothera workflow does not generalize to another manufacturer or model. Reporting to MedWatch does not mean a report is required, prove what caused the message, or replace either the manufacturer’s support route or your clinical plan.
Questions for your prescribing office
Is my current plan still active, and for how many sessions?
Saving keeps this on your device and needs JavaScript, which is off in this browser.Do you need a visit, a form, or a record from me before you re-authorize?
Saving keeps this on your device and needs JavaScript, which is off in this browser.Has the follow-up you wanted from me been done?
Saving keeps this on your device and needs JavaScript, which is off in this browser.
Why I will not help you bypass the counter
I will not tell you how to invent or store a code, bypass a counter, estimate remaining treatments, or treat what I have written here as authorization. Follow your current prescribed plan and your device’s exact instructions. Evidence Evidence Evidence This statement has a dated source and is waiting for a clinician's sign-off. Pending clinical review
How to use this step
- Limited evidence
A support checklist can organize a phone call. It cannot change your clinical plan or your device’s state. Federal rule restricts a prescription device to sale by, or on the order of, a licensed practitioner. What authorizes your use is that order and its labeling, never a checklist, a counter reading, or a support call.
Check before moving on
- Depends on you
Only your prescriber and the manufacturer’s official routes can resolve your exact situation. The federal rule sets the labeling and distribution requirement; it does not settle your plan, transfer a prescription, or override state law.
Questions for your prescribing office
Am I currently authorized to continue treatment?
Saving keeps this on your device and needs JavaScript, which is off in this browser.
Applicability check
Who was studied?
These fields show what the cited evidence reports about the people and body sites behind outcome or safety claims. “Not reported” means the reviewed source omitted the field; “Pending exact source review” means SteadySkin has not made that determination yet.
I will not tell you how to invent or store a code, bypass a counter, estimate remaining treatments, or treat what I have written here as authorization. Follow your current prescribed plan and your device’s exact instructions.
- Age range
- Not reported
- Condition subtype
- Not reported
- Severity or extent
- Not reported
- Sample size
- Not reported
- Geography and care setting
- Sources are a US federal regulation (21 CFR 801.109) and manufacturer support documents. Neither is a study. Neither reports an enrolled population.
- Skin tone or phototype
- Not reported
- Race
- Not reported
- Ethnicity
- Not reported
- Body sites
- Not reported
What that means for this page: eCFR 801.109 restricts a prescription device to sale by, or on the order of, a licensed practitioner. It does not decide one private transaction, transfer a prescription, or override state law. The manufacturer documents are support material, not a study of who bypasses a counter or how often. None of the three settles whether continuing without resolving the message is safe for one person. That is the prescriber’s call.
Evidence behind this page
Sources
Each evidence badge opens the source and its limits. The full list stays available here.
- Phothera PhototherapyManufacturer document · Manufacturer, tier 4Independence not established
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports the current first-party route to Phothera device and accessory manuals and shows that instructions are model- and controller-specific.
What it does not support
It does not establish clinical suitability, comparative benefit, the condition of an individual unit, or that one manual applies to a related or legacy model; each exact linked manual and revision still requires verification.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- Solarc Systems Inc.Manufacturer document · Manufacturer, tier 4Independence not established
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports one page of the named SolRx E-Series manual revision, its specifications page. That page carries the models covered, the narrowband waveband, the bulb type and count, the nominal irradiance figures with their stated caution, and the per-device electrical and fuse ratings. It does not support another SolRx family, confirm that this is the newest revision for an individual unit, establish clinical suitability, or prove comparative safety or effectiveness; the owner must verify the exact current manual with Solarc.
What it does not support
The linked file is that one page, not the whole manual. It does not carry the installation, protective-equipment, maintenance or support sections that the rest of the manual holds.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Independent source
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports that FDA posted an open Class II recall record for the exact Phothera 600/ClearLink population identified in that record and directs potentially affected owners to the firm’s official notice and technical-service route.
What it does not support
It does not apply to every Phothera product, every controller or every home phototherapy device, and it must not be used without checking the exact current model, unit identifiers, software scope, dates, and recall status in the live FDA record.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Independent source
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports that patients, consumers, and health professionals can use FDA MedWatch to report serious reactions, product-quality problems, product-use errors, and other serious problems involving human medical products, including medical devices.
What it does not support
It does not determine whether a report is required, prove causation, replace clinical care, or replace the manufacturer’s equipment-support route.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- Electronic Code of Federal RegulationsRegulatory · Regulatory / guideline, tier 1Independent source
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports the federal prescription-device labeling and distribution framework.
What it does not support
It does not decide whether a specific private transaction is lawful, replace state law, authorize a seller, transfer a prescription, or establish that a used unit is safe or supported.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Independent source
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports that FDA publishes a device recall register a reader can search directly by firm legal name. On 22 August 2026 that search returned six Class II records with an ongoing status for the firm that makes these units, covering several phototherapy models and the ClearLink control system software. The register files them under that firm legal name rather than the brand printed on a device. It also spells the product line two different ways across the returned records, so a search on one product name alone does not return them all. Two of the six describe a software fault on resuming an interrupted treatment.
What it does not support
It does not establish that any record covers a particular unit. That depends on the serial numbers, item numbers, software versions and dates inside each record, and it does not show which of the listed models are sold for home use. It does not connect any recall to a refill, counter or authorization message, and it does not say a device is unsafe. It does not decide whether anyone should pause, resume or change treatment. The register is updated continuously, so the count and the status of each record must be re-read live rather than taken from this date.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- PhotheraManufacturer document · Manufacturer, tier 4Relevant relationship disclosed
- Published
- SteadySkin last checked
What this source can and cannot tell you
Why the independence label says this: This is first-party support information from a device manufacturer.
What this source supports
Supports the manufacturer-specific route of contacting the prescribing office when a Phothera unit indicates that authorization is needed.
What it does not support
It does not authorize treatment, apply to another manufacturer, or support inventing, storing, bypassing or reproducing an authorization code.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.