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510(k) K252994

LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) by Guangdong Ace-Tec Co., Ltd. — Product Code OHS

K252994 is an FDA 510(k) premarket notification submitted by Guangdong Ace-Tec Co., Ltd. for the device "LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)". The FDA issued a decision of Substantially Equivalent on Dec 8, 2025. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 8, 2025
Date Received
Sep 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over The Counter Wrinkle Reduction
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.

Other clearances for product code OHS

  • K260767 — Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beau (Aug 31, 2026)
  • K261602 — Eye Recovery Pro (PH-e03) (Aug 10, 2026)
  • K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) (Aug 7, 2026)
  • K261851 — LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML (Aug 4, 2026)
  • K261496 — LED Light Therapy Masks (PE748, PE749, PE756) (Aug 4, 2026)
  • K261482 — LightStim for Wrinkles (1984); LightStim for Acne (2038) (Jul 31, 2026)
  • K260598 — 5 Wavelength LED Facemask (TN2508) (Jul 24, 2026)
  • K261407 — XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPR (Jul 15, 2026)
  • K261473 — Chromix (Jul 1, 2026)
  • K261052 — LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) (Jun 29, 2026)

FDA data resources