IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K240583
- Device name
- IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-03-01
- Decision date
- 2024-06-18
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBodyOther
- 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 body and/or facial hair.
Intended Use
IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
The IPL Home Use Hair Removal Device is the professional IPL in five levels or nine levels and offers a beauty experience in comfort of your own home as well as has been designed with unique features for simple, relaxed and effective hair removal. IPL Home Use Hair Removal Device includes D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W sixteen models. All have adopted basically identical structure design, consisting of IPL host and power adapter two parts, which the host is mainly composed of lamp cartridge, display screen, power and/or level button, indicator, skin sensor, fan, flash button and DC socket. D-T099K, D-T099KW, D-1196B, D-1196W do not contain the Ice-Cooling function. D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196C, D-1196C1 have Ice-Cooling function and only perform the hair removal and cold compress function simultaneously. D-T012, D-T012W have Ice-Cooling function and it is able to perform the hair removal and cold compress function simultaneously or separately.
Summary parsed at:2026-06-11 04:44:46 UTC
Predicate devices
3IPL Home Use Hair Removal Device
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
K240583 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K240583 as a predicate