Home / 510(k) Clearances / K200929

510(k) K200929

Hair Growth System by Xuzhou Kernel Medical Equipment Co., Ltd. — Product Code OAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2020
Date Received
April 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Comb, Hair
Device Class
Class II
Regulation Number
890.5500
Review Panel
SU
Submission Type

Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v

Other clearances by Xuzhou Kernel Medical Equipment Co., Ltd.

  • K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-50 (February 6, 2025)
  • K222751 — LED Light Therapy Device, KN-7000L (February 1, 2023)
  • K200971 — 308nm Excimer System (December 15, 2020)
  • K190685 — Hair Growth System (July 26, 2019)
  • K181805 — UV Phototherapy (January 11, 2019)
  • K160341 — Colposcope System (September 14, 2016)
  • K132643 — UV PHOTOTHERAPY (January 30, 2014)

Other clearances for product code OAP

  • K253669 — TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) (January 23, 2026)
  • K253349 — Hair Regrowth Cap (Model: T-119-HRC) (December 24, 2025)
  • K252414 — Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) (October 30, 2025)
  • K252325 — Hair Growth Laser Cap (October 22, 2025)
  • K251017 — CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) (June 17, 2025)
  • K250467 — Red Light Hair Growth Cap (LP-RJVGRW-BLK) (June 5, 2025)
  • K250308 — Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, K (April 29, 2025)
  • K242747 — FAQ™ (302) (December 11, 2024)
  • K242619 — GroWell BT Hair Growth System (GW10042) (December 2, 2024)
  • K242363 — HIGHERDOSE Red Light Hat (HG-120K) (November 20, 2024)