General and Plastic Surgery · PMA · 2011
MELAFIND
STRATA SKIN SCIENCES, INC.. Approved by FDA on 1 November 2011 under submission P090012, product code OYD (optical diagnostic device for melanoma detection). What FDA's record says, in FDA's words.
Device record · P090012
- Device. MELAFINDDEVICE
- Company. STRATA SKIN SCIENCES, INC.COMPANY
- Decision. 1 November 2011, PMA, aprlDECISION
- Panel. General and Plastic SurgeryPANEL
- Product code. OYD, Optical Diagnostic Device For Melanoma DetectionCODE
- Regulation. 21 CFR 878.1820, Class IIREG
- Source. FDA database entrySOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
The product code's definition, from FDA's classification record. An optical diagnostic device for melanoma detection is a prescription device that measures and analyzes optical properties of a skin lesion. The device is intended for use by a physician trained in the clinical diagnosis and management of skin cancer as an adjunctive device following identification of a suspicious skin lesion. The output given by the device is intended to be used in combination with clinical and historical signs of skin cancer to obtain additional information prior to a decision to biopsy. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis. Please reference https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code OYD. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OYD, in General and Plastic Surgery, or approved in 2011. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.