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#
- 3005580113
- 2125050
- 3001431138
- 3003288808
- 3014384451
- 3000313549
- 3009736547
- 3010359222
- 1319639
- 3006680097
- 3048246437
- 3004940677
- 1222993
- 3037047060
- 3036240802
- 3015077548
- 3034246188
- 1725006
- 3011024620
- 3009078366
- 3016678045
- 3005205318
- 3011302631
- 3027725665
- 3007689729
- 3043127589
- 3017954802
- 3010912900
- 3030090167
- 9610617
- 3001605696
- 1225450
- 1221275
- 3027605507
- 3043657394
- 3009298127
- 3018116888
- 3002808227
- 3008156177
- 3013789508
- 3015151147
- 3002807715
- 3021334828
- 3007674911
- 2031934
- 3008085016
- 3004111573
- 3012440264
- 3004361445
- 3004529369
- 3014310779
- 3004633032
- 1037955
- 3005180774
- 3019252665
- 3017264244
- 1000548922
- 3012133441
- 3042641021
- 3008915316
- 3034456223
- 1035236
- 3013602304
- 9611516
- 3008442971
- 3044175602
- 3002807636
- 3002736133
- 3043140693
- 1419951
- 3032147807
- 3021380980
- 3013557562
- 3037874486
- 3009462521
- 3011670002
- 3003542872
- 3013697074
- 9611388
Source Documents#
Other 510(k) Records For Product Code GEX#
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|---|---|---|---|
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| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-09-02 |
| 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 |