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Bare: 808

Luvo Medical Technologies, Inc.

Country / region:Canada (CA)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Luvo Medical Technologies, Inc.
Canada (CA)

Product code

GEX
21 CFR 878.4810

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1
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Cited as predicate

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Device details

FDA 510(k) registration fields

K number
K193446
Device name
Bare: 808
Company
Luvo Medical Technologies, Inc.
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

1

K193446 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K193446 as a predicate