510(k) K041212
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2004
- Date Received
- May 10, 2004
- Clearance Type
- Special
- 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