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510(k) K230107

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 by Kam Yuen Plastic Products , Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2023
Date Received
January 13, 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 Kam Yuen Plastic Products , Ltd.

  • K213027 — Laser Hair Growth Comb (May 26, 2022)
  • K213025 — Laser hair growth helmet (May 12, 2022)
  • K212907 — Aimanfun Lumea Comfort, A-2789/A-3588 (December 2, 2021)
  • K190820 — Aimanfun Lumea Comfort (October 2, 2019)

Other clearances for product code OHT

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  • 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)
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  • 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)