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510(k) K230060

Light Based Hair Removal Device GP592 by Shenzhen Gsd Tech Co., Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2023
Date Received
January 9, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over-The-Counter Hair Removal
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Over-the-counter device uses thermal energy to kill hair follicles for hair removal.

Other clearances by Shenzhen Gsd Tech Co., Ltd.

  • K213225 — Diode Laser System GP900A8, Diode Laser System GP900Q8 (December 22, 2021)
  • K202827 — 308nm Excimer UV-light Skin Therapy System (December 15, 2020)
  • K191518 — CO2 Laser System (September 12, 2019)
  • K180383 — Light based hair removal device (May 11, 2018)
  • K142186 — DIODE LASER HAIR REMOVAL SYSTEM (April 17, 2015)
  • K091664 — GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C (November 16, 2009)

Other clearances for product code OHT

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  • K253666 — IPL Hair Removal Device (Models: T31A, T32A) (February 23, 2026)
  • K253881 — Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033M (December 29, 2025)
  • K253754 — Philips Lumea IPL (December 23, 2025)
  • K253304 — IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-2 (November 25, 2025)
  • K253035 — IPL Hair Removal Device (SYL001AZ, SYL002AZ) (November 19, 2025)
  • K252618 — IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) (November 14, 2025)
  • K252234 — IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA (October 14, 2025)
  • K252209 — IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM0 (October 10, 2025)
  • K251398 — IPL Hair Removal Device (IPL-001, IPL-002) (October 2, 2025)