Manufacturer
Luvo Medical Technologies, Inc.Bare: 808
Luvo Medical Technologies, Inc.
Country / Region:Canada (CA)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K193446
- Device name
- Bare: 808
- Country / Region
- Canada(CA)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-12-12
- Decision date
- 2020-03-10
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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. Use on all skin types (Fitzpatrick I-VI) including tanned skin.
Intended Use
The hair removal single (HRS) and hair removal moving (HRM) modes are intended for permanent reduction in hair regrowth defined as 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. Use on all skin types (Fitzpatrick I-VI) including tanned skin.
Device Description
The Bare: 808 Laser System consists of a console, a touch screen user interface, a footswitch, and 1 handpiece. It is a powered laser surgical instrument intended for use in dermatologic and general surgical procedures.
Summary parsed at:2026-06-01 05:47:17 UTC
Predicate devices
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Not ingested
K193446 references 1 predicate/reference device
Cited as predicate
11 submission cite K193446 as a predicate