Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.

Zhuzhou Goldenhot Medical Technology Co., Ltd.

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

Product code OHT· 21 CFR 878.4810

View Summary PDF

Product code

OHT
21 CFR 878.4810

Predicate devices

2

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K231613
Device name
Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-06-02
Decision date
2023-07-31
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
FaceBodyOther
Primary application
Body
Classification source
AI classified

Indications for Use

The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.

Intended Use

The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.

Device Description

The Intense pulsed light device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. The Device includes DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G twelve models. All have adopted the same structure design, consisting of Intense pulsed light device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. The difference of all models is mainly product size, appearance, sapphire, skin color recognition function and enclosure color. DE01A series means without sapphire and skin color recognition function. DE01B series means with sapphire, but without skin color recognition function. DE01C series means with sapphire and skin color recognition function. DE02A series means without sapphire and skin color recognition function. DE02B series means with sapphire, but without skin color recognition function. DE02C series means with sapphire and skin color recognition function. Letter -B indicates the enclosure color is blue, letter -G is green, which do not affect the intended use.

Summary parsed at:2026-06-11 04:40:16 UTC

Predicate devices

2

K231613 references 2 predicate/reference devices

Cited as predicate

3

3 submissions cite K231613 as a predicate