Sunbed/Sunroof or Suncouch/Sunsky
by Sunfit, Inc.
510(k) K801542
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801542 | Date20 Aug 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
This device is a Booth, Sun Tan, classified under FDA regulation 878.4635. It is designed as a sun-tanning booth or sunroof/suncouch system, providing controlled exposure to ultraviolet (UV) radiation for cosmetic tanning purposes. The device is intended for use in environments where individuals can safely and effectively achieve a sun-tanned appearance without direct outdoor sun exposure.
The Sunbed/Sunroof or Suncouch/Sunsky is supplied as a reusable device and is intended for use in commercial or professional settings, such as tanning salons. It has received FDA 510(k) clearance (K801542) under the Substantially Equivalent (SESE) determination, classified as a Class II medical device. No specific sterility or MRI safety information is provided, and its use is regulated under the General & Plastic Surgery advisory committee category. The device is identified by the product code LEJ and adheres to the regulatory framework outlined in the FDA’s classification system.
Other devices from Sunfit, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Sunfit Sunbed/Suncouch Sunsky used for?
The Sunfit Sunbed/Suncouch Sunsky is designed for controlled exposure to ultraviolet (UV) radiation in commercial or professional settings, such as tanning salons. It provides a safe way for individuals to achieve a sun-tanned appearance indoors without direct outdoor sun exposure. The device is classified under FDA regulation 878.4635 as a Booth, Sun Tan, and is intended solely for cosmetic tanning purposes.
Is the Sunbed/Suncouch Sunsky a single-use or reusable device?
The Sunbed/Suncouch Sunsky is a reusable device. It is intended for repeated use in commercial environments like tanning salons, where it can be operated multiple times for different clients. There is no mention of sterility requirements, so proper cleaning and maintenance protocols should be followed to ensure safe and hygienic use.
What regulatory approval does the Sunbed/Suncouch Sunsky hold?
The Sunbed/Suncouch Sunsky has received FDA 510(k) clearance under the Substantially Equivalent (SESE) determination, classified as a Class II medical device. The clearance number is K801542, and it falls under the General & Plastic Surgery advisory committee category. The device is regulated under product code LEJ and adheres to FDA classification system 878.4635.
What types of environments is this device intended for?
This device is specifically designed for use in commercial or professional environments, such as tanning salons. It is not intended for home use or personal ownership. The controlled UV exposure provided by the Sunbed/Suncouch Sunsky is meant for safe, supervised use in settings where trained personnel can ensure proper operation and client safety.
Are there any specific storage requirements for the Sunbed/Suncouch Sunsky?
While the provided data does not explicitly detail storage requirements, as a reusable device intended for commercial use, it should be stored in a clean, dry environment when not in operation. Proper maintenance, including regular cleaning and inspection, is recommended to ensure the device remains functional and safe for use. Always follow manufacturer guidelines for optimal storage and care.