FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FREEDOM ND: YAG LASER SYSTEM
K Number: K113843
·
Decision Sep 27, 2012
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
18
Applicant Total
29
Review Days
274
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
- FREEDOM ND: YAG LASER SYSTEM
- K Number
- K113843
- 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
- Lutronic Corporation
- Date Received
- December 28, 2011
- Decision Date
- September 27, 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 Lutronic Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251327 | XERF | Aug 11, 2025 | Substantially Equivalent |
| K244060 | eCO2 3D | Jul 31, 2025 | Substantially Equivalent |
| K213748 | CoreLevee | Oct 14, 2022 | Substantially Equivalent |
| K213569 | HOLLYWOOD SPECTRA Laser System | Feb 4, 2022 | Substantially Equivalent |
| K203788 | DermaV Laser System | Mar 26, 2021 | Substantially Equivalent |
| K183566 | CLARITY II Laser System | Jun 14, 2019 | Substantially Equivalent |
| K180945 | LUTRONIC GENIUS Radiofrequency System | Dec 10, 2018 | Substantially Equivalent |
| K173700 | PICOPLUS Laser System | Jun 19, 2018 | Substantially Equivalent |
| K171009 | LASEMD Laser System | Jun 23, 2017 | Substantially Equivalent |
| K163196 | ACTION II Laser System | May 24, 2017 | Substantially Equivalent |