IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)

Foshan Jindi Electric Appliance 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

3

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K252209
Device name
IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-07-15
Decision date
2025-10-10
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyUnderarmBikini / BrazilianOther
Primary application
Body
Classification source
AI classified

Indications for Use

IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. Applicable skin types are Fitzpatrick skin types I-V. Treatment areas include limbs, armpits, back, chest, bikini, and small areas (e.g., lip).

Intended Use

IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Device Description

IPL Home Use Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using 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. IPL Home Use Hair Removal Device includes five models, JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032. The five models adopt identical intended use, similar performance, operation and structure, with main differences in appearance, dimensions and weight, and light output parameters. Models JD-TM016, JD-TM023 are single pulse devices while models JD-TM027, JD-TM028 and JD-TM032 are double pulses devices. The device is only powered by the external power adapter. This device adopts sapphire flash outlet that is suitable for multiple hair removal areas. The device is fitted with a skin sensor to detect appropriate skin contact, if the flash outlet 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. The device has a cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

Summary parsed at:2026-06-11 04:31:37 UTC

Predicate devices

3

K252209 references 3 predicate/reference devices

Cited as predicate

1

1 submission cite K252209 as a predicate