Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)

Shenzhen Jianchao Intelligent Technology Co., Ltd.

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

Product code OHT· 21 CFR 878.4810

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Product code

OHT
21 CFR 878.4810

Predicate devices

5

Cited as predicate

2

Device details

FDA 510(k) registration fields

K number
K242710
Device name
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-09-09
Decision date
2024-12-06
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
BodyFace
Primary application
Body
Classification source
AI classified

Indications for Use

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

Intended Use

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

Device Description

Hair Removal Device (Model: R3C16-P, R3C16-W, R3C16-G; R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro), is an over-the-counter, home-use and personal device for hair reduction based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. Hair Removal Device includes two series (R3C16 series and R3505 series) with a total of 10 models. The two series products adopt identical intended use, similar performance and operation, consisting of IPL host and power adapter, which the host is mainly composed of lamp tube, filter, display screen, buttons, thermoelectric cooler, fan, and DC socket. The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by manual finger switch or auto light emission. All models of the Hair Removal Device have a cooling function for a better hair removal experience, but the main difference is that the model with 'Pro' in the model name is equipped with sapphire while the model without 'Pro' uses metal treatment window surface. The difference of design between models are listed below: Model(s) Enclosure color Cooling function Product drawing R3C16-P Purple Metal cooling R3C16-W White Metal cooling R3C16-G Golden Metal cooling R3C16-P Pro Purple Sapphire cooling R3C16-W Pro White Sapphire cooling R3C16-G Pro Golden Sapphire cooling R3505-W White Metal cooling R3505-B Black Metal cooling R3505-W Pro White Sapphire cooling R3505-B Pro Black Sapphire cooling.

Summary parsed at:2026-06-11 04:48:20 UTC

Predicate devices

5

K242710 references 5 predicate/reference devices

Cited as predicate

2

2 submissions cite K242710 as a predicate