Sun Tanning Bed Model EC-3RF
510(k) K853692
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853692 | Date1 Oct 1985 | 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- Withdrawn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
- FTC
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4630
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Sun Tanning Bed Model EC-3RF is a dermatological device that emits ultraviolet light for tanning purposes. It is classified as a light, ultraviolet, dermatological device intended for use in general and plastic surgery settings.
This device is supplied by Mottek Intl. Corp. and has FDA 510(k) clearance with decision code SESE. The device is class 2 and regulated under product code FTC. It is not specified as single-use or reusable, and no information regarding MRI safety, sterility, or storage conditions is provided.
Other devices from Mottek Intl. Corp.
Questions
AI-generated answers, 26 Sep 2026
What is the Sun Tanning Bed Model EC-3RF used for?
The Sun Tanning Bed Model EC-3RF is a dermatological device that emits ultraviolet light for tanning purposes. It is intended for use in general and plastic surgery settings.
How is the Sun Tanning Bed Model EC-3RF supplied?
The device is supplied by Mottek Intl. Corp. No information is provided regarding whether it is single-use or reusable, or if it requires special storage conditions.
What is the regulatory status of the Sun Tanning Bed Model EC-3RF?
The device has FDA 510(k) clearance with decision code SESE, indicating it is substantially equivalent to predicate devices. It is classified as class 2 and regulated under product code FTC.
Is the Sun Tanning Bed Model EC-3RF sterile?
No information regarding sterility is provided for the Sun Tanning Bed Model EC-3RF in the available device data.