Venus Epileve

Venus Concept USA, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K200786
Device name
Venus Epileve
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-03-26
Decision date
2020-06-09
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for:
• Hair removal;
• Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen);
• Treatment of pseudofolliculitis barbae.

Intended Use

The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for: • Hair removal; • Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and • Treatment of pseudofolliculitis barbae.

Device Description

The Venus Epileve device consists of a tabletop console (main unit) and one detachable diode laser applicator. The system console is the main enclosure that holds and contains all external and internal system components: a power supply unit, laser diode driver, controller unit, and touch screen with LCD display. The console incorporates a water cooling system with a pump in order to constantly keep the tip of the applicator, light guide, chilled. The detachable diode laser applicator is connected to the system via a cable passed through the applicator connectors located in the designated compartment on the system's rear side. When not in use, the applicator can be secured within the applicator cradle on the top panel of the console. The applicator delivers the laser energy to a patient's skin through the applicator's tip made of a sapphire light guide framed in aluminum anodized shells. The device also comes with a footswitch, goggles, patient eye protectors, and water filling kit. The Venus Epileve delivers laser energy to the patient's skin via the diode laser applicator connected to the console. The console utilizes diode laser module as sources of optical energy and the optical output is fiber-coupled through the applicator to the treatment area. Pulsed laser energy emitted by the system is absorbed by melanin in the hair follicles, which have greater optical absorption at the selected laser wavelength than the surrounding tissue. The selective absorption leads to localized heating and thermal denaturation of the target with minimal effect on the surrounding tissues. The short- and long-term impact of the selective photo thermolysis on hair subparts caused by diode laser energy emitted into the skin leads to hair removal and permanent hair reduction. The laser applicator has an integrated contact skin cooling system to enhance safety and comfort during the treatment. The device incorporates several safety features, including an emergency laser stop button, user login and password protection, and other software and hardware settings to mitigate the risk of improper energy release and ensure that system outputs are within specifications.

Summary parsed at:2026-06-01 05:48:03 UTC

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