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510(k) K213056

LED Facial Mask by Shenzhen Osto Technology Company Limited — Product Code OLP

K213056 is an FDA 510(k) premarket notification submitted by Shenzhen Osto Technology Company Limited for the device "LED Facial Mask". The FDA issued a decision of Substantially Equivalent on July 7, 2022. The device falls under product code OLP (Over-The-Counter Powered Light Based Laser For Acne), a Class II device regulated under 21 CFR 878.4810. Shenzhen Osto Technology Company Limited has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2022
Date Received
September 22, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Powered Light Based Laser For Acne
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

Other clearances by Shenzhen Osto Technology Company Limited

  • K211942 — Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) (December 13, 2021)
  • K211736 — Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST (September 5, 2021)
  • K210756 — Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H (June 11, 2021)
  • K190783 — Health Expert Electronic Stimulator (model: AST-300L) (March 14, 2020)
  • K190673 — Health Expert Electronic Stimulator (December 12, 2019)
  • K133929 — HEALTH EXPERT ELCTRONIC STIMULATOR (November 12, 2014)

Other clearances for product code OLP

  • K253878 — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) (March 4, 2026)
  • K251843 — Erchonia EVRL (September 12, 2025)
  • K242068 — LED Light Therapy Mask (RT01) (April 4, 2025)
  • K243555 — LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, (February 5, 2025)
  • K232656 — BLU TOTALE (Model: ENEOB852) (November 14, 2023)
  • K230490 — PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-N (October 27, 2023)
  • K230720 — LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 (July 3, 2023)
  • K220729 — The Luminance RED Acne Device (June 9, 2022)
  • K213039 — Micro-current facial cold and hot service (model: TPML-100) (May 25, 2022)
  • K210545 — Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light hea (May 20, 2022)

FDA data resources