Manufacturer
El Global Trade, Ltd.Sensilight Pro / Pistol 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
- K183260
- Device name
- Sensilight Pro / Pistol 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
- 2018-11-23
- Decision date
- 2019-03-18
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBodyOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The Sensilight Pro device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured 6, 9, and 12 months after the completion of treatment regimen.
Intended Use
The Sensilight Pro device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured 6, 9, and 12 months after the completion of treatment regimen.
Device Description
The Sensilight Pro is an intense pulse light hair reduction device. Phototherapy (Light-based) hair reduction is based on the theory of selective photothermolysis in which optical energy is used to disable hair re-growth. The Sensilight Pro is composed of a hand-held applicator and an external power supply/charger. The spot size (treatment area) in the Sensilight Pro is 4.5 cm² or 2 cm² (for large and precise treatment windows, respectively). The device contains a lamp, a skin proximity and pigmentation sensor allowing application only on compatible skin tones and while in full contact with the treated area. If the Sensilight Pro is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the device will provide indications on the faulty conditions and will not trigger a pulse.
Summary parsed at:2026-06-11 04:25:27 UTC
Predicate devices
2—
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Not ingested
Beurer IPL 8500 device/ IPL VelvetSkin Pro
K183260 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K183260 as a predicate
