Manufacturer
Shenzhen Junbobeauty Technology Co., Ltd.IPL HAIR REMOVAL HANDSET, Model: IPL-666
Shenzhen Junbobeauty Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K220669
- Device name
- IPL HAIR REMOVAL HANDSET, Model: IPL-666
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-03-07
- Decision date
- 2022-05-16
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyFaceLegsBikini / Brazilian
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL HAIR REMOVAL HANDSET is an over-the-counter device intended for removal of unwanted body and/or facial hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen. The device is designed for use on the legs, underarms, bikini line, chest, stomach, back, arms and on the face below the cheekbones. Removal of unwanted body hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
Intended Use
IPL HAIR REMOVAL HANDSET is an over-the-counter device intended for removal of unwanted body and/or facial hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description
The device includes a treatment window head, a facial adaptor, and a battery charger/AC cord. It is a handheld device powered by an external power supply with an input of 100-240V AC and an output of 12V 3A. The light source is Intense Pulsed Light, and the energy medium is a Xenon Quartz Tube. The wavelength range is 470nm to 1100nm, with a maximum energy density of 2.49J/cm² and a spot size of 3cm².
Summary parsed at:2026-06-11 04:31:48 UTC
Predicate devices
2IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
K220669 references 2 predicate/reference devices
Cited as predicate
7IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
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.
IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
IPL Hair Removal, Model: W-1095, W-1098
Intense Pulse Light Therapeutic Apparatus
7 submissions cite K220669 as a predicate