510(k) Report

FDA applicant

Dermal Photonics Corporation

Danvers, MA2 decisions2017–20230 recalls

FDA records 2 decisions for Dermal Photonics Corporation (Danvers, MA) from 2017 to 2023: 2 510(k) clearances. All are in product code OHS (Light Based Over The Counter Wrinkle Reduction). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dermal Photonics Corp”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Dermal Photonics Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 12023: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Dermal Photonics Corporation by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dermal Photonics Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Dermal”

FDA records each applicant name separately; these may or may not be the same firm.