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510(k) K230720

LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 by Light Tree Ventures Europe B.V. — Product Code OLP

K230720 is an FDA 510(k) premarket notification submitted by Light Tree Ventures Europe B.V. for the device "LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001". The FDA issued a decision of Substantially Equivalent on July 3, 2023. 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. Light Tree Ventures Europe B.V. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2023
Date Received
March 16, 2023
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 Light Tree Ventures Europe B.V.

  • K260415 — myLEDmask 2 (MJ-144) (May 12, 2026)
  • K253349 — Hair Regrowth Cap (Model: T-119-HRC) (December 24, 2025)
  • K223893 — Infrared Heat (Model: E0221) (May 16, 2023)
  • K230597 — Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) (April 28, 2023)
  • K230042 — Q-Rejuvalight Pro Facewear (Model: P19-0023) (April 28, 2023)
  • K230336 — CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) (April 5, 2023)
  • K230124 — LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) (March 15, 2023)
  • K223642 — LED Lip Perfector, model: ZC-05 (March 9, 2023)
  • K221775 — LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) (December 20, 2022)
  • K221444 — LED Eye Perfector, model: EY-36A, EY-36B (December 8, 2022)

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)
  • 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)
  • K210545 — Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light hea (May 20, 2022)

FDA data resources