FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AviClear Laser System
K Number: K251149
·
Decision Jul 11, 2025
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
10
Review Days
88
Basic Information
- Device Name
- AviClear Laser System
- K Number
- K251149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cutera, Inc.
- Date Received
- April 14, 2025
- Decision Date
- July 11, 2025
- 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 Cutera, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233237 | xeo+ Family | Dec 15, 2023 | Substantially Equivalent |
| K230660 | AviClear Laser System | Jun 6, 2023 | Substantially Equivalent |
| K213461 | AviClear Laser System | Mar 24, 2022 | Substantially Equivalent |
| K182997 | enlighten III Laser System | Dec 12, 2018 | Substantially Equivalent |
| K180709 | truSculpt RF Device; truSculpt; truSculpt 3D | Jun 6, 2018 | Substantially Equivalent |
| K172077 | Cutera enlighten III Laser System | Oct 27, 2017 | Substantially Equivalent |
| K172004 | truSculpt | Aug 2, 2017 | Substantially Equivalent |
| K170936 | Cutera enlighten III Laser System | Apr 25, 2017 | Substantially Equivalent |
| K160488 | Cutera enlighten III Laser System | Oct 28, 2016 | Substantially Equivalent |