510(k) K100678
- Device
- SUPRA SCAN DELIVERY SYSTEM
- Applicant
- QUANTEL MEDICAL
- 510(k) number
- K100678
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-21
- Date received
- 2010-03-10
- 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
- Yes
Applicant Contact#
- Contact
- PATRICK QUERO
- Address
- 21 Rue Newton; Zi Le Brezet Clermont Ferrand FR 63039 63039
FDA Registration Numbers#
- 3010359222
- 3042255006
- 8021543
- 3008925277
- 1820334
- 1038823
- 1000121056
- 3037966040
- 2438558
- 3013613043
- 3016170453
- 3013557562
- 3037047060
- 2953684
- 3014226003
- 3017181358
- 9611516
- 3026360847
- 3019559090
- 3018318562
- 3006082230
- 3008156177
- 3006427656
- 3026400760
- 3021380980
- 3040278150
- 3033274371
- 3020611964
- 3042262496
- 2011171
- 1423662
- 3020770009
- 3038356864
- 2953696
- 3011310540
- 3015452693
- 2031934
- 3017638059
- 2938071
- 1928237
- 3038373471
- 3016181563
- 3012125201
- 3035375056
- 3010511300
- 3034995492
- 3004475754
- 3011024620
- 3005099803
- 2027755
- 3010933841
- 2528981
- 3012911444
- 3043012074
- 3031582430
- 1647149
- 2032513
- 1825146
- 3006546131
- 3006807694
- 3004858034
- 3031233199
- 1419951
- 3014132468
- 1222993
- 9680671
- 3017140525
- 3016661372
- 3025379728
- 3018094310
- 3012322232
- 3008776882
- 2183911
- 3005972890
- 9681260
- 3012301874
- 8030987
- 2011068
- 3003340844
Source Documents#
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026-07-21 |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | 2026-07-17 |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | 2026-07-16 |
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | 2026-06-18 |
| K261570 | PICOSURE WORKSTATION | Cynosure, LLC | 2026-06-17 |
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | 2026-06-04 |
| K260138 | LUNE PureHygiene | Enamel Pure | 2026-05-29 |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | 2026-05-29 |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | 2026-05-21 |
| K260100 | MOSES Raydar™ | Boston Scientific Corporation | 2026-05-18 |
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | 2026-05-11 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-05-07 |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | Leaseir Technologies, Slu | 2026-05-04 |
Legacy Summary#
summary
FDA Review#
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