510(k) K861963
K861963 is an FDA 510(k) premarket notification submitted by Ultralite for the device "ULTRALITE HF1236 HAND AND FOOT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 25, 1986. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Ultralite has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 1986
- Date Received
- May 20, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Ultraviolet, Dermatological
- Device Class
- Class II
- Regulation Number
- 878.4630
- Review Panel
- SU
- Submission Type