510(k) K063834
- Device
- REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM
- Applicant
- HOYA CONBIO, INC
- 510(k) number
- K063834
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-01-25
- Date received
- 2006-12-26
- 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
- DONNA TEMPLEMAN
- Address
- 1105 Sunset Creek Ln. Pleasanton CA US 94566 94566
FDA Registration Numbers#
- 1424263
- 3030495752
- 3010220595
- 3016076077
- 3007549439
- 3007336385
- 3004111573
- 3005739661
- 2032092
- 3043149902
- 3010511300
- 3010175098
- 3002808227
- 3030230686
- 3025104654
- 3030125922
- 3010273372
- 3012452798
- 3006515340
- 9680671
- 3016096097
- 3023808190
- 3043011436
- 3009444646
- 3017200975
- 3021011208
- 1000391004
- 3042641021
- 3017400436
- 2031763
- 1319639
- 2246552
- 3004710757
- 3005282635
- 2647580
- 3015907115
- 3008729892
- 3010364538
- 3014737458
- 2031934
- 3010027944
- 1219930
- 3014577013
- 3006617841
- 1928237
- 3011555967
- 3014388884
- 3017638059
- 3011024620
- 3013397886
- 3015730775
- 3008915316
- 3010683226
- 3025268687
- 3011302631
- 3034630389
- 1064858
- 3020221089
- 3012133441
- 3042228064
- 3032147807
- 3016661372
- 3016496662
- 3017140525
- 1820334
- 3030420005
- 8043792
- 3014144061
- 3017124433
- 3002736133
- 3007712511
- 3040278150
- 2027755
- 3002806603
- 3005941719
- 3030233762
- 3004483538
- 3007085226
- 3037874486
Source Documents#
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | 2026-05-29 |
| K260138 | LUNE PureHygiene | Enamel Pure | 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 |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 |
| 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 |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026-04-29 |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | 2026-04-22 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-04-20 |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | 2026-04-15 |
Legacy Summary#
summary
FDA Review#
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