IBL 5000 Tanning Booth
by Ibl Acquisitions, LLC 510(k)
Active
510(k) K152405
Overview
The IBL 5000 Tanning Booth is a Booth, Sun Tan device intended for the tanning of human skin. It is classified under medical specialty General, Plastic Surgery and has been determined to be substantially equivalent to a predicate device.
The device received FDA 510(k) clearance under K152405 on September 1, 2016, with product code LEJ and regulation number 878.4635. It is manufactured by Ibl Acquisitions, LLC and is intended for use in accordance with its cleared indications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152405 | Date1 Sep 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LEJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4635
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the IBL 5000 Tanning Booth used for?
The IBL 5000 Tanning Booth is intended for the tanning of human skin, as specified in its FDA 510(k) clearance, and is classified under the medical specialties of General and Plastic Surgery.
How is the IBL 5000 Tanning Booth supplied or configured for use?
The device is a booth-style sun tan unit designed for stationary use in clinical or professional settings, as indicated by its classification as a 'Booth, Sun Tan' device under FDA product code LEJ.
Is the IBL 5000 Tanning Booth reusable or single-use?
The IBL 5000 Tanning Booth is a reusable device, as it is a fixed booth unit intended for repeated use in accordance with its cleared indications and manufacturer instructions.
What regulatory pathway was used for the IBL 5000 Tanning Booth?
The IBL 5000 Tanning Booth received FDA 510(k) clearance under submission K152405 on September 1, 2016, demonstrating substantial equivalence to a predicate device under regulation number 878.4635 and product code LEJ.