FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The Alma Hybrid Laser System
K Number: K251230
·
Decision May 21, 2025
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
20
Review Days
30
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Basic Information
- Device Name
- The Alma Hybrid Laser System
- K Number
- K251230
- 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
- Alma Lasers, Inc.
- Date Received
- April 21, 2025
- Decision Date
- May 21, 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 Alma Lasers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251684 | Alma TED+ System | Jun 5, 2026 | Substantially Equivalent |
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| K243044 | Alma Harmony | Apr 11, 2025 | Substantially Equivalent |
| K233024 | Alma Harmony | Feb 8, 2024 | Substantially Equivalent |
| K230308 | Alma Harmony | Mar 1, 2023 | Substantially Equivalent |
| K230371 | The Alma Soprano Titanium | Feb 22, 2023 | Substantially Equivalent |
| K222064 | The Alma Soprano Titanium | Oct 12, 2022 | Substantially Equivalent |
| K201520 | The Alma Opus System, Colibri Applicator and Tips | Oct 27, 2021 | Substantially Equivalent |
| K181298 | Harmony XL Multi-Application Platform | Jun 13, 2018 | Substantially Equivalent |
| K172193 | Modified Alma Lasers Soprano XL Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules | Jan 9, 2018 | Substantially Equivalent |