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510(k) K192295

PDT-FACE by Beijing Adss Development Co., Ltd. — Product Code OLP

K192295 is an FDA 510(k) premarket notification submitted by Beijing Adss Development Co., Ltd. for the device "PDT-FACE". The FDA issued a decision of Substantially Equivalent on May 1, 2020. 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. Beijing Adss Development Co., Ltd. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2020
Date Received
August 23, 2019
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 Beijing Adss Development Co., Ltd.

  • K241670 — Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy Syst (December 20, 2024)
  • K233307 — Intensity Pulsed Light Therapy System (March 15, 2024)
  • K231896 — Diode Laser Therapy System (February 20, 2024)
  • K231318 — Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) (July 7, 2023)
  • K220268 — Picosecond Laser System (Model PS10-A and PS10-B) (August 23, 2022)
  • K161926 — ND YAG Q-switch Laser Therapy Machine (February 22, 2017)
  • K161692 — Diode Laser Therapy Machine (November 16, 2016)
  • K161925 — CO2 Laser Therapy Machine (October 5, 2016)
  • K161286 — IPL Therapy Machine (August 4, 2016)

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)
  • K213056 — LED Facial Mask (July 7, 2022)
  • K220729 — The Luminance RED Acne Device (June 9, 2022)
  • K213039 — Micro-current facial cold and hot service (model: TPML-100) (May 25, 2022)

FDA data resources