510(k) K221623
- Device
- FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
- Applicant
- Gme German Medical Engineering GmbH
- 510(k) number
- K221623
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-10
- Date received
- 2022-06-06
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dietmar Fischer
- Address
- Dreikoenigstr. 6-8 Erlangen DE 91054 91054
FDA Registration Numbers#
- 3009488834
- 3009380063
- 3005580113
- 3013619029
- 3011657089
- 3037047060
- 3038373471
- 3042255006
- 3005855240
- 3006849754
- 3004111573
- 3009649442
- 3016170453
- 3004378299
- 1318319
- 3003340844
- 3043011436
- 1222993
- 3012322232
- 3004633032
- 3034456223
- 3004374705
- 3037966040
- 3005791808
- 3019906161
- 3020900954
- 3009383334
- 3038197172
- 3046005941
- 2939653
- 3012133441
- 3015807001
- 3025268687
- 1319211
- 3007583504
- 3021349626
- 1037955
- 3043012240
- 3009887511
- 1424785
- 3017140525
- 3009736547
- 3016496662
- 1000393132
- 3015779311
- 2124215
- 1000523114
- 3030543531
- 3008965332
- 3008915316
- 3019252665
- 3008252121
- 3015730775
- 3033274371
- 3042641021
- 3011024620
- 1419951
- 3005205318
- 3016746323
- 3010724743
- 3045892905
- 3011644607
- 3010363436
- 3005739661
- 3004884150
- 3010281590
- 3007535734
- 3010053203
- 2521877
- 3017173524
- 3006695864
- 2031763
- 3011743768
- 3039396569
- 3017200975
- 9615030
- 2032513
- 3006985163
- 3005972890
Source Documents#
Other 510(k) Records For Product Code GEX#
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| K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | 2026-09-01 |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-08-27 |
| K261964 | ECHOLASER X4 | Elesta S.P.A | 2026-08-19 |
| K262070 | Diode Laser Therapy Systems (DL612A) | Hebei Zollvan Medical Technology Co., Ltd. | 2026-08-19 |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | 2026-08-11 |
| K261221 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | 2026-07-24 |