IPL Home Use Hair Removal Device— 510(k) K221001

Name: FDA 510(k) clearance K221001
Creator: U.S. Food and Drug Administration
Published: 2022-05-12

Substantially Equivalent

Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.

FDA 510(k) clearance K221001 for IPL Home Use Hair Removal Device, Substantially Equivalent on 2022-05-12. Applicant: Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.
Product code: Product code OHT
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2022-04-04
Decision date: 2022-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OHT

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K262352 — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)2026-10-09
K261975 — Braun Aura 7 (6041)2026-09-30
K261977 — Braun Aura 9 (6042)2026-09-25
K262524 — Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)2026-09-18
K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)2026-08-10

More clearances from Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.

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K240583 — IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)2024-06-18
K211185 — IPL Home Use Hair Removal Device2021-12-20
K211922 — IPL Home Use Hair Removal Device2021-09-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.