510(k) K221306
- Device
- SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
- Applicant
- Gyrus Acmi, Inc.
- 510(k) number
- K221306
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-27
- Date received
- 2022-05-05
- 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
- Jon Gilber
- Address
- 800 W. Park Dr. Westborough MA US 01581 01581
FDA Registration Numbers#
- 3007336385
- 3029083714
- 3010511300
- 3014388884
- 3014980477
- 3021159346
- 3009887511
- 3027605646
- 3013404959
- 3008206114
- 3012639861
- 3026540840
- 3012133441
- 3009383334
- 3033524191
- 3031233197
- 3007674911
- 1043653
- 3017173524
- 3000313549
- 3044175602
- 3015730775
- 3007535734
- 1226486
- 2245304
- 1928237
- 3004475754
- 3013041594
- 3010314781
- 3014226003
- 9611388
- 3033884002
- 3011555967
- 1219930
- 3008729892
- 3006546131
- 3010912900
- 3039396569
- 1220477
- 3004069780
- 3011310540
- 9612147
- 3033715699
- 3030979014
- 2438558
- 3010273872
- 3012289707
- 3011024620
- 3005515469
- 3014222368
- 3023344923
- 3004858034
- 3004940677
- 3007689716
- 3008156177
- 9710340
- 1820334
- 3005855240
- 3013515803
- 3010683226
- 3031233199
- 3004135191
- 1420032
- 3022327202
- 3005791808
- 3003683459
- 3032916575
- 8043564
- 3030733800
- 3008085016
- 3007712511
- 3027851853
- 1424263
- 3005801723
- 3009462521
- 3026038437
- 3006786907
- 3001431138
- 3030979156
Source Documents#
Other 510(k) Records For Product Code GEX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-04-09 |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | 2026-03-31 |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | 2026-03-28 |
| K260632 | LASER THERMAL THERAPY KIT | Elesta S.P.A | 2026-03-17 |
| K252971 | Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | 2026-03-17 |