Nirvana
by El.En S.P.A. 510(k)
Active
510(k) K234057
Overview
The Nirvana is a laser hair removal device classified under the FDA’s General and Plastic Surgery category (product code GEX). It is designed for non-invasive hair removal and permanent hair reduction, targeting hair follicles to inhibit regrowth over time. The device employs laser technology to selectively destroy hair follicles while preserving surrounding skin tissue. Permanent hair reduction is assessed at 6, 9, and 12 months post-treatment.
The device is supplied as a medical instrument intended for use in clinical settings by trained professionals. It is cleared under the FDA’s Traditional 510(k) pathway and is classified as a Class 2 device. No specific sterility or single-use/reusable designation is stated in the regulatory data. The device’s regulatory submission (K234057) was reviewed by the FDA’s Skin and Soft Tissue (SU) Advisory Committee and received a Substantially Equivalent (SESE) determination. No MRI safety or storage specifications are provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK234057 | Date10 Apr 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from El.En S.P.A.
Questions
What is the Nirvana laser hair removal device used for?
The Nirvana device is designed for non-invasive hair removal and permanent hair reduction. It uses laser technology to selectively target and destroy hair follicles, reducing regrowth over time. Results are typically assessed at 6, 9, and 12 months post-treatment, making it suitable for clinical settings where long-term hair reduction is desired.
How is the Nirvana device supplied and intended for use?
The Nirvana is supplied as a medical instrument intended exclusively for use in clinical settings by trained professionals. It is cleared under the FDA’s Traditional 510(k) pathway and falls under the General and Plastic Surgery category (product code GEX). The device is not specified as single-use or reusable in the regulatory data.
Is there any information about sterility or reusability for the Nirvana device?
The available regulatory data for the Nirvana device does not explicitly state whether it is sterile, single-use, or reusable. Clinicians should follow standard infection control protocols and manufacturer guidelines to ensure safe use, as these details are not provided in the submission.
What regulatory pathway was followed for the Nirvana laser hair removal device?
The Nirvana device was cleared through the FDA’s Traditional 510(k) pathway, classified as a Class 2 device. Its regulatory submission (K234057) was reviewed by the Skin and Soft Tissue (SU) Advisory Committee and determined to be Substantially Equivalent (SESE) to a predicate device. This classification ensures it meets FDA standards for safety and effectiveness.
Are there any special storage requirements for the Nirvana device?
The regulatory data for the Nirvana device does not specify any particular storage requirements, such as temperature or environmental conditions. However, standard medical device storage practices should be followed to maintain its functionality and ensure longevity, particularly if the device is intended for reuse.