Sunlamp (F40-UVB & F20-UVB)
510(k) K760482
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760482 | Date15 Sep 1976 | 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- Withdrawn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, 21 Sep 2026
The Sunlamp (F40-UVB & F20-UVB) is a Light, Ultraviolet, Dermatological device. It is substantially equivalent to other devices and is classified as a device class 2. The device is used for dermatological purposes.
The Sunlamp (F40-UVB & F20-UVB) is supplied with a product code of FTC and is regulated under regulation number 878.4630. It has been assigned a k number of K760482 and has received FDA 510(k) clearance. The device is intended for use in general and plastic surgery medical specialties.
Other devices from Dermatron Corp.
Questions
AI-generated answers, 21 Sep 2026
What is the Sunlamp used for?
The Sunlamp is used for dermatological purposes, including general and plastic surgery medical specialties.
Is the Sunlamp supplied sterile?
The device data does not specify if the Sunlamp is supplied sterile, it is recommended to consult the manufacturer's instructions for use.
What is the regulatory classification of the Sunlamp?
The Sunlamp is classified as a device class 2, regulated under regulation number 878.4630, and has received FDA 510(k) clearance.