Manufacturer
El Global Trade, Ltd.micro IPL
Country / Region:Israel (IL)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
- K172181
- Device name
- micro IPL
- Company
- El Global Trade, Ltd.
- Country / Region
- Israel(IL)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-07-19
- Decision date
- 2017-10-13
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBodyOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The micro IPL is an over the counter device intended for removal of unwanted body and/or facial hair in adults. The micro IPL is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Intended Use
The micro IPL is an over the counter device intended for removal of unwanted body and/or facial hair in adults. The micro IPL is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Device Description
The micro IPL device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The micro IPL device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the micro IPL device is 3 cm2. The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the micro IPL is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the micro IPL will not trigger a pulse.
Summary parsed at:2026-06-11 04:22:47 UTC
