510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K222685Substantially Equivalent

NIRA Model 2

Dermal Photonics Corp, Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222685 is the FDA 510(k) clearance record for NIRA Model 2, a class II device, cleared for Dermal Photonics Corp on under FDA product code OHS (Light Based Over The Counter Wrinkle Reduction). FDA's definition for product code OHS reads: "Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided". FDA records list 2 510(k) clearances for Dermal Photonics Corp, from to . As of , FDA records show no recalls naming K222685.

Clearance record

Decision date
Received
(155 days to decision)
Product code
OHS Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Dermal Photonics Corp 153 Andover St., Suite 111, Danvers MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OHS

Trailing 12 months
35 clearances under product code OHS in the twelve months to October 2026, December 2025 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code OHS, trailing twelve months
MonthClearances
November 20253
December 20258
January 20263
February 20262
March 20264
April 20261
May 20261
June 20264
July 20264
August 20265
September 20260
October 20260