Skip to content

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.

by Zhuzhou Goldenhot Medical Technology Co., Ltd.

510(k) K231613

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 NumberK231613 Date31 Jul 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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is an Intense Pulsed Light Device, classified as a Light-Based Over-The-Counter Hair Removal system. It emits controlled pulses of broad-spectrum light to selectively target and reduce hair follicles, promoting hair reduction on body and facial areas. The technology leverages selective photothermolysis to minimize damage to surrounding skin while targeting melanin in hair shafts. Multiple model variants are designed for varying skin tones and treatment areas, ensuring versatility in clinical and at-home use.

The device is supplied as a single-use or reusable system, depending on model specifications, and is intended for over-the-counter use. It is non-sterile and requires proper handling and storage per manufacturer guidelines. The device is MRI-unsafe and must be removed before MRI procedures. Models are categorized by size and intended treatment area, with regulatory compliance confirmed under FDA 510(k) clearance (K231613). Authorized for General and Plastic Surgery applications, it adheres to FDA regulation 878.4810 for light-based hair removal systems.

Other devices from Zhuzhou Goldenhot Medical Technology Co., Ltd.