Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)

Shenzhen Chuangtong Yigou 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

3

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K251000
Device name
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-04-01
Decision date
2025-06-30
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
UnderarmLegsArmsBikini / Brazilian
Primary application
Underarm
Classification source
AI classified

Indications for Use

Hand-held Hair Removal Device is indicated for the 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. The device is used for adults with Fitzpatrick skin types I - IV. Treatment areas include upper lip, chin, underarms, legs, arms, bikini area, chest, back, and abdomen.

Intended Use

Hand-held Hair Removal Device is indicated for the 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

Hand-held Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL). The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is powered by an external power adapter and its IPL emission activation is by finger switch. It has an irreplaceable light exit and can cover an area of 3.0cm2, suitable for multiple hair removal areas, such as upper lip, chin, underarms, legs, arms, bikini area, chest, back, abdomen. The device contains a skin sensor to detect appropriate skin contact, ensuring that the treatment light pulses are emitted only when in full contact with the skin. Additionally, it has a cooling function (suitable for model CT05, CT06, CT07, CT08, CT09) that can be activated throughout the hair removal process to cool down the treatment area's temperature.

Summary parsed at:2026-06-11 04:29:25 UTC

Predicate devices

3

K251000 references 3 predicate/reference devices

Cited as predicate

1

1 submission cite K251000 as a predicate