IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
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
- K181568
- Device name
- IPL Salon Hair Reduction System
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-06-14
- Decision date
- 2018-09-11
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBodyOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. 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.
Intended Use
The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. 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
IPL Salon Hair Reduction System, Model: F60001, a small over-the-counter device, is a home-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). Emission activation is by finger switch. Device includes a treatment window head, a facial adaptor and battery charger/AC cord. It is used AC Powered (100-240 V AC; 50/60 Hz). The weight of the device is 650g, and the size is 143 x 69.5 x 43mm (H*W*D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Summary parsed at:2026-06-11 04:24:43 UTC
Predicate devices
2Cited as predicate
9IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
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IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
9 submissions cite K181568 as a predicate