GME ExSys 308
FDA 510(k) K150752 · Gme (German Medical Engineering) GmbH
510(k) numberK150752
Submission
- Device name
- GME ExSys 308
- Applicant
- Gme (German Medical Engineering) GmbH
Nuerenberg, Bavaria, DE - Received
- March 23, 2015
- Decision date
- July 31, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
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More from Psoria-Shield, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGEX · Traditional | 03/10/2023SE |
| K203054 | FlexSysGEX · Traditional | 03/05/2021SE |
| K192269 | TwinScan 808/755 Laser SystemGEX · Traditional | 11/19/2019SE |
| K180518 | GME LinScan Lite 808 Laser SystemGEX · Traditional | 07/23/2018SE |
| K141063 | Linscan 808, Linscan 980GEX · Traditional | 07/15/2014SE |
Questions and answers
When was GME ExSys 308 cleared by the FDA?
GME ExSys 308 (K150752) received a 510(k) decision of Substantially Equivalent on July 31, 2015, 130 days after the submission was received.
What is the product code of K150752?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.