Skip to content

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588

by Kam Yuen Plastic Products, Ltd.

510(k) K230107

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230107 Date5 Apr 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OHT
FDA applicant
Kam Yuen Plastic Products , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lumea Comfort (Models A-2788, A-2789, A-3588) is a light-based over-the-counter hair removal device designed for at-home use. It employs laser technology to target and reduce hair growth on the skin’s surface, suitable for various skin tones and body areas.

This device is intended for single-use per session and is classified as a Class II medical device under FDA regulations. Supplied as a non-sterile, non-reusable unit, it requires no special storage conditions beyond keeping it dry and protected from physical damage. The device holds an FDA 510(k) clearance for substantial equivalence under the product code OHT, with authorization number K230107.

Other devices from Kam Yuen Plastic Products, Ltd.