Suntanning Lamp
510(k) K864907
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864907 | Date5 Jan 1987 | 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- Withdrawn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 Suntanning Lamp is a Light, Ultraviolet, Dermatological device. It is used to tan the skin.
The device is supplied by Interlectric Corp. and has a product code of FTC. It is classified as a class 2 device and has a regulation number of 878.4630. The device has been cleared by the FDA with a Traditional clearance type and is substantially equivalent. It is used in General and Plastic Surgery settings.
Other devices from Interlectric Corporation
Questions
AI-generated answers, 21 Sep 2026
What is the Suntanning Lamp used for?
The Suntanning Lamp is used to tan the skin, and is used in General and Plastic Surgery settings.
Is the Suntanning Lamp a single-use or reusable device?
The device data does not specify whether the Suntanning Lamp is single-use or reusable, but it is classified as a class 2 device.
What are the regulatory clearances for the Suntanning Lamp?
The Suntanning Lamp has been cleared by the FDA with a Traditional clearance type and is substantially equivalent, with a regulation number of 878.4630.