Manufacturer
Home Well Trading, Ltd.Beurer IPL 8500 device/ IPL VelvetSkin Pro
Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Company
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K181734
- Device name
- Beurer IPL 8500 device/ IPL VelvetSkin Pro
- Company
- Home Well Trading, Ltd.
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-07-02
- Decision date
- 2018-09-19
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
AN OVER-THE-COUNTER HOME USE DEVICE INTENDED FOR HAIR REDUCTION BASED ON INTENSE PULSED LIGHT (IPL)
Intended Use
AN OVER-THE-COUNTER HOME USE DEVICE INTENDED FOR HAIR REDUCTION BASED ON INTENSE PULSED LIGHT (IPL)
Device Description
The Beurer IPL 8500 device 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 Beurer IPL 8500 device is composed of a hand-held applicator and an external power supply/charger. The spot size (treatment area) in the Beurer IPL 8500 device 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 Beurer IPL 8500 device 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 04:24:54 UTC
Predicate devices
2—
—
Not ingested
Lumilisse IPL Hair Remover
K181734 references 2 predicate/reference devices
Cited as predicate
1Sensilight Pro / Pistol IPL
1 submission cite K181734 as a predicate