510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K200983Substantially Equivalent

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine

Ningbo Hesi Electric Co., Ltd., Ningbo, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200983 is the FDA 510(k) clearance record for Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine, a class II device, cleared for Ningbo Hesi Electric 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 one 510(k) clearance for Ningbo Hesi Electric Co., Ltd. As of , FDA records show no recalls naming K200983.

Clearance record

Decision date
Received
(456 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
Ningbo Hesi Electric Co., Ltd. #818-23-156 Qiming Rd., Yinzhou, Ningbo City Zhejiistrict,, Ningbo, 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