K-number	K253666
Device name	IPL Hair Removal Device (Models: T31A, T32A)
Applicant	Shenzhen Mlay Intelligent Technology Co., Ltd.
Product code	OHT
Device class	Class II
Decision date	Feb 23, 2026
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The IPL Hair Removal Device (Models T31A, T32A) is an over-the-counter, light-based hair reduction device using Intense Pulsed Light technology with cooling capability. It is intended for removal of unwanted hair and for permanent reduction in hair regrowth, with efficacy measured at 6, 9, and 12 months post-treatment.

Technological characteristics

The device uses Xenon Arc Flashlamp energy with wavelength range 510-1200nm (same as predicate K251176), maximum fluence of 6.48 J/cm², spot size of 5.4 cm² (larger than predicates but not raising safety concerns), and pulse duration of 0.4–0.92ms multipulse (within predicate range). It includes semiconductor-based cooling via Peltier effect and auto-recognition skin tone sensing.

Test standards cited

ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization), ISO 10993-23 (irritation); IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83 (electrical safety and EMC); IEC 62471 (photobiological safety).

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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IPL Hair Removal Device (Models: T31A, T32A)

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