FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
K Number: K211401
·
Decision Jun 3, 2021
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
42
Review Days
28
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Basic Information
- Device Name
- SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- K Number
- K211401
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gyrus Acmi, Inc.
- Date Received
- May 6, 2021
- Decision Date
- June 3, 2021
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Gyrus Acmi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Mar 2, 2026 | Substantially Equivalent |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) | Mar 25, 2024 | Substantially Equivalent |
| K231327 | POWERSEAL Sealer and Divider | Oct 25, 2023 | Substantially Equivalent |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories | Jan 27, 2023 | Substantially Equivalent |
| K212650 | Celeris, Disposable Sinus Debrider | Jan 19, 2022 | Substantially Equivalent |
| K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle | Jan 4, 2022 | Substantially Equivalent |
| K181696 | ChitoZolve | Nov 30, 2018 | Substantially Equivalent |
| K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter | Mar 8, 2018 | Substantially Equivalent |
| K170908 | PK AIM | May 19, 2017 | Substantially Equivalent |
| K163373 | PK AIM | Dec 12, 2016 | Substantially Equivalent |