510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250581Substantially Equivalent

KALA Red Light Face Mask (KALA-01)

Shenzhen Kaiyan Medical Equipment Co., Ltd, Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250581 is the FDA 510(k) clearance record for KALA Red Light Face Mask (KALA-01), a class II device, cleared for Shenzhen Kaiyan Medical Equipment Co., Ltd. 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 24 510(k) clearances for Shenzhen Kaiyan Medical Equipment Co., Ltd., from to . As of , FDA records show no recalls naming K250581.

Clearance record

Decision date
Received
(92 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
Shenzhen Kaiyan Medical Equipment Co., Ltd. Bldg.#3 And Bldg.#5, 40th Of Fuxin St., Shenzhen, CN
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