510(k) K903660
K903660 is an FDA 510(k) premarket notification submitted by Solitec GmbH for the device "DERMALIGHT PSORACOMB". The FDA issued a decision of Substantially Equivalent on July 17, 1991. The device falls under product code IOB (Lamp, Infrared, Non Heating), a Class II device regulated under 21 CFR 890.5500. Solitec GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1991
- Date Received
- August 10, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Infrared, Non Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type