IPL Hair Removal Device (Models: T31A, T32A)— 510(k) K253666
Substantially EquivalentShenzhen Mlay Intelligent Technology Co., Ltd.
FDA 510(k) clearance K253666 for IPL Hair Removal Device (Models: T31A, T32A), Substantially Equivalent on 2026-02-23. Applicant: Shenzhen Mlay Intelligent Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Mlay Intelligent Technology's IPL Hair Removal Device lists models T31A and T32A under product code OHT (Light Based Over-The-Counter Hair Removal). The record doesn't say how the two differ.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
Shenzhen Mlay Intelligent Technology filed from Shenzhen, China. FDA found it substantially equivalent 94 calendar days after receipt (November 21, 2025 to February 23, 2026).
Clearance details
- Applicant
- Shenzhen Mlay Intelligent Technology Co., Ltd.
- Product code
- Product code OHT
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OHT
view all- K262352 — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
- K261975 — Braun Aura 7 (6041)
- K261977 — Braun Aura 9 (6042)
- 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)
- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
More clearances from Shenzhen Mlay Intelligent Technology Co., Ltd.
view all- K251176 — IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
- K241106 — Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
- K240264 — Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)
Data sourced from openFDA. This site is unofficial and independent of the FDA.