510(k) K060338
- Device
- FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
- Applicant
- LUMENIS, INC.
- 510(k) number
- K060338
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-03-09
- Date received
- 2006-02-10
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Connie Hoy
- Address
- 2400 Condensa St. Santa Clara CA US 95051 95051
FDA Registration Numbers#
- 3006427656
- 9615030
- 3005099803
- 9613462
- 2020550
- 3016661372
- 3033511105
- 3010627091
- 3008442971
- 3011670002
- 1423662
- 3019252665
- 1225450
- 3022327202
- 3009040934
- 1820334
- 2953696
- 3030125922
- 3020770009
- 3003708273
- 3008627763
- 2031934
- 3021011208
- 3004497289
- 2954354
- 3012669557
- 3037047060
- 1000121056
- 2938071
- 3015658550
- 1000393132
- 3011555967
- 3016413636
- 3014144061
- 3019559090
- 3015262665
- 3042261306
- 2247224
- 3013529876
- 3001431138
- 3007156625
- 3013917867
- 3017144492
- 3009488834
- 1318319
- 3039396569
- 3012799115
- 1018470
- 1018233
- 3027619554
- 1644312
- 3016746323
- 3006247712
- 1225072
- 2183744
- 3036240802
- 3038189188
- 2125050
- 3012301874
- 3025268687
- 3012911444
- 3015151147
- 2438558
- 3012125201
- 2134812
- 3005205318
- 3025861981
- 3007712511
- 3021315370
- 3012294783
- 3003015433
- 3031233199
- 3013619029
- 9611388
- 3031233197
- 3011412640
- 2938889
- 1221275
- 3002807636
Source Documents#
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026-04-29 |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | 2026-04-22 |
Legacy Summary#
summary
FDA Review#
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