FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
K Number: K113810
·
Decision Mar 8, 2012
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
18
Applicant Total
20
Review Days
76
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
- K Number
- K113810
- 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
- Alma Lasers, Inc.
- Date Received
- December 23, 2011
- Decision Date
- March 8, 2012
- Product Code
- PDZ
- 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 |
|---|---|---|---|
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PDZ), ordered by most recent decision date.
Medicell Mycosis Laser (MCML24004)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Onycho Laser V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TFX-LT2000 Therapy Light
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AF Laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REMY Medical Therapy Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LunulaLaser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Alma Lasers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251684 | Alma TED+ System | Jun 5, 2026 | Substantially Equivalent |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories | Sep 24, 2025 | Substantially Equivalent |
| K251230 | The Alma Hybrid Laser System | May 21, 2025 | Substantially Equivalent |
| 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 |