510(k) K150752
K150752 is an FDA 510(k) premarket notification submitted by Gme (German Medical Engineering) GmbH for the device "GME ExSys 308". The FDA issued a decision of Substantially Equivalent on July 31, 2015. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Gme (German Medical Engineering) GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2015
- Date Received
- March 23, 2015
- 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