510(k) K862608
K862608 is an FDA 510(k) premarket notification submitted by Cooper-Hewitt Electric Co. for the device "SPERTILITE PHOTOTHERAPY LAMP". The FDA issued a decision of SN on August 6, 1986. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Cooper-Hewitt Electric Co. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- August 6, 1986
- Date Received
- July 8, 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