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IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32

Shenzhen Yangyi Technology ., Ltd.

Country / Region:China (CN)Submission type:Traditional

Product code OHT· 21 CFR 878.4810

Summary PDF

Company

Shenzhen Yangyi Technology ., Ltd.
China (CN)

Product code

OHT
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

3
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Device details

FDA 510(k) registration fields

K number
K230021
Device name
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
Company
Shenzhen Yangyi Technology ., Ltd.
Country / Region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-01-04
Decision date
2023-03-31
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
FaceBodyLegsUnderarm
Primary application
Body
Classification source
AI classified

Indications for Use

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair. Applicable skin Fitzpatrick Skin Phototypes I-V. Treatment area includes facial hair below the chin line, arms, legs, underarms, and bikini line. Removal of unwanted body hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

Intended Use

IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Device Description

The IPL Hair Removal Device includes: AP10, AP20, AP30, AP32 four models. Their intended use, performance, structure design and operation, are essential the same for the device models, with main differences being product appearance, display contents, physical product dimension, treatment area (spot size), output energy and power supply.

Summary parsed at:2026-06-11 04:37:41 UTC

Predicate devices

2

K230021 references 2 predicate/reference devices

Cited as predicate

3

3 submissions cite K230021 as a predicate