General and Plastic Surgery · De Novo · 2024
DermaSensor
DermaSensor Inc.. Granted by FDA on 12 January 2024 under submission DEN230008, product code QZS (software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer). What FDA's record says, in FDA's words.
Device record · DEN230008
- Device. DermaSensorDEVICE
- Company. DermaSensor Inc.COMPANY
- Decision. 12 January 2024, De NovoDECISION
- Panel. General and Plastic SurgeryPANEL
- Product code. QZS, Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin CancerCODE
- Regulation. 21 CFR 878.1830, Class IIREG
- Source. FDA database entry · decision document (33 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
The DermaSensor device is indicated for use to evaluate skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and above to assist in the decision regarding referral of the patient to a dermatologist. The DermaSensor device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists. The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool. The device should not be used as the sole diagnostic criterion nor to confirm clinical diagnosis of skin cancer. De Novo Summary (DEN230008)
The product code's definition, from FDA's classification record. A software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer is a prescription device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion. The device is intended for use by a physician not trained in the clinical diagnosis and management of skin cancer as an adjunctive second-read device following identification of a suspicious skin lesion. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 11 reports filed against devices carrying product code QZS. 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. The latest reports, in the reporter’s words:
9 February 2026 · Malfunction · DERMASENSOR · DERMASENSOR INC · report 3017254-2025-00011
THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL […]
2 February 2026 · Malfunction · DERMASENSOR · DERMASENSOR INC · report 3017254-2025-00010
THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL […]
27 January 2026 · Malfunction · DERMASENSOR · DERMASENSOR INC · report 3017254-2025-00002
THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL […]
27 January 2026 · Malfunction · DERMASENSOR · DERMASENSOR INC · report 3017254-2025-00003
THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL […]
27 January 2026 · Malfunction · DERMASENSOR · DERMASENSOR INC · report 3017254-2025-00004
THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL […]
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 QZS, in General and Plastic Surgery, or granted in 2024. The whole record is at FDA AI-enabled medical devices.
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