Venus Epileve
510(k) K200786
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200786 | Date9 Jun 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Venus Epileve is a tabletop diode laser system designed for laser hair removal. As a medical laser device, it emits controlled laser energy to selectively target and destroy hair follicles, reducing unwanted hair growth on the face and body across various skin types. Its classification under the FDA’s General, Plastic Surgery advisory committee reflects its intended use in cosmetic and dermatological settings for hair removal procedures.
Supplied as a reusable device, the Venus Epileve is intended for use in clinical or aesthetic practice environments. It incorporates real-time cooling technology to enhance patient comfort during treatments. The device operates under FDA clearance (K200786) as a substantially equivalent product, adhering to regulatory standards for safety and efficacy in laser hair removal applications. Storage and maintenance instructions are manufacturer-specific and must be followed to preserve device performance and sterility.
Other devices from Venus Concept USA, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Venus Epileve used for?
The Venus Epileve is a medical-grade laser system designed specifically for laser hair removal procedures. It emits controlled laser energy to selectively target and reduce hair follicles, making it suitable for cosmetic and dermatological applications on both facial and body areas. Its FDA clearance under the General, Plastic Surgery advisory committee confirms its intended use for improving hair removal outcomes across various skin types.
Is the Venus Epileve a single-use or reusable device?
The Venus Epileve is a reusable device intended for use in clinical or aesthetic practice settings. Its design allows for repeated use in professional environments, provided that manufacturer-specific storage and maintenance guidelines are strictly followed to ensure performance, safety, and sterility over time.
How does the Venus Epileve enhance patient comfort during treatments?
The Venus Epileve incorporates real-time cooling technology, which helps minimize discomfort during laser hair removal sessions. This feature is particularly beneficial for patients undergoing treatments on sensitive areas, as it reduces skin irritation and improves overall tolerance to the procedure.
What regulatory approval does the Venus Epileve hold?
The Venus Epileve holds FDA clearance (K200786) as a substantially equivalent product under the General, Plastic Surgery advisory committee. This classification confirms that the device meets regulatory standards for safety and efficacy in laser hair removal applications, ensuring it adheres to established medical device guidelines.
Where can the Venus Epileve be used?
The Venus Epileve is intended for use in clinical or aesthetic practice environments, such as dermatology clinics, cosmetic surgery centers, or medspas. Its tabletop design and professional-grade specifications make it suitable for controlled settings where precise laser hair removal treatments are performed.