Flourescent T12 Uva Tanning Lamp
FDA 510(k) K853545 · Light Sources, Inc.
510(k) numberK853545
Submission
- Device name
- Flourescent T12 Uva Tanning Lamp
- Applicant
- Light Sources, Inc.
Ansonia, CT, US - Received
- August 26, 1985
- Decision date
- October 1, 1985
- 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 |
| K900693 | U.V. Sunlamp (U.V. Light, Dermatologic)FTC · Traditional | 03/27/1990SE |
| 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 |
Questions and answers
When was Flourescent T12 Uva Tanning Lamp cleared by the FDA?
Flourescent T12 Uva Tanning Lamp (K853545) received a 510(k) decision of Substantially Equivalent on October 1, 1985, 36 days after the submission was received.
What is the product code of K853545?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.