Nordic Sun Home Tanning Unit
FDA 510(k) K860567 · Nordic Sun Corporation of America
510(k) numberK860567
Submission
- Device name
- Nordic Sun Home Tanning Unit
- Applicant
- Nordic Sun Corporation of America
Stamford, CT, US - Received
- February 14, 1986
- Decision date
- March 5, 1986
- 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 |
|---|---|---|
| K860566 | Nordic Sun 24 Lamp Tanning BedFTC · Traditional | 03/05/1986SE |
Questions and answers
When was Nordic Sun Home Tanning Unit cleared by the FDA?
Nordic Sun Home Tanning Unit (K860567) received a 510(k) decision of Substantially Equivalent on March 5, 1986, 19 days after the submission was received.
What is the product code of K860567?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.