U.V. Sunlamp (U.V. Light, Dermatologic)
FDA 510(k) K900693 · Light Sources, Inc.
510(k) numberK900693
Submission
- Device name
- U.V. Sunlamp (U.V. Light, Dermatologic)
- Applicant
- Light Sources, Inc.
Ansonia, CT, US - Received
- February 13, 1990
- Decision date
- March 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
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More from Psoria-Shield, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151370 | UV Lamps for Indoor Tanning DevicesLEJ · Traditional | 12/17/2015SE |
| K901324 | U.V. Sunlamp 95UF-IIFTC · Traditional | 04/26/1990SE |
| K900649 | Fluorescent T12 Uva LampFTC · Traditional | 03/28/1990SE |
| K883952 | U. V. Sunlamp 95UF-11FTC · Traditional | 09/28/1988SE |
| K874889 | U.V. Sunlamp 95 UF-11FTC · Traditional | 12/30/1987SE |
| K870167 | U.V. Sunlamp 95UF-11FTC · Traditional | 02/09/1987SE |
| K854004 | Fluorescent T12 Uva Tanning LampFTC · Traditional | 10/29/1985SE |
| K853545 | Flourescent T12 Uva Tanning LampFTC · Traditional | 10/01/1985SE |
Questions and answers
When was U.V. Sunlamp (U.V. Light, Dermatologic) cleared by the FDA?
U.V. Sunlamp (U.V. Light, Dermatologic) (K900693) received a 510(k) decision of Substantially Equivalent on March 27, 1990, 42 days after the submission was received.
What is the product code of K900693?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.