SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
FDA 510(k) clearance K221306 · decided 2023-01-27
Clearance details
- K-number
- K221306
- Device name
- SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
- Applicant
- Gyrus Acmi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-05
- Decision date
- 2023-01-27
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Westborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Spiration® Valve System (P180007/S013) | Gyrus Acmi, Inc. | 2024-08-16 |
| Spiration Valve System Deployment Catheter and Loader (P180007/S012) | Gyrus Acmi, Inc. | 2024-06-27 |
| Spiration Valve System (P180007/S011) | Gyrus Acmi, Inc. | 2023-09-22 |
| SVS Deployment Catheter and Loader (P180007/S009) | Gyrus Acmi, Inc. | 2022-05-12 |
| Spiration Valve System (P180007/S008) | Gyrus Acmi, Inc. | 2021-09-01 |
| Falope Ring Band and Applicator Systems (P870076/S027) | Gyrus Acmi, Inc. | 2021-05-19 |
| Falope-Ring® Band and Applicator Systems (P870076/S026) | Gyrus Acmi, Inc. | 2021-05-11 |
| Spiration® Valve System (SVS) (P180007/S007) | Gyrus Acmi, Inc. | 2020-12-23 |