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510(k) K253073

LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) by Sunglor Technology Co., Ltd. — Product Code OHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2025
Date Received
September 23, 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 by Sunglor Technology Co., Ltd.

  • K253086 — LED Light Therapy Device (Models: SG-FM, SG-FE) (December 19, 2025)

Other clearances for product code OHS

  • K253874 — LED Therapy Light (COB1400, HP1800PRO) (March 3, 2026)
  • K253683 — FAQ™ (LED Panel); FAQ™ (Dual LED Panel) (February 20, 2026)
  • K254007 — LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) (February 12, 2026)
  • K253833 — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD0 (January 30, 2026)
  • K252603 — HIGHERDOSE Body Sculptor (Model: GS-03) (January 28, 2026)
  • K253712 — LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, (January 23, 2026)
  • K253400 — LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X (December 24, 2025)
  • K253279 — Feather/numiere 05 06 07 (05) (December 24, 2025)
  • K253135 — LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1 (December 23, 2025)
  • K253054 — LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) (December 19, 2025)