The PL-1064 Laser System
FDA 510(k) K120938 · Sheaumann Laser, Inc.
510(k) numberK120938
Submission
- Device name
- The PL-1064 Laser System
- Applicant
- Sheaumann Laser, Inc.
Oviedo, FL, US - Received
- March 22, 2012
- Decision date
- September 24, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDZ – Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
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| K123014 | Litecure Therapy System Model LTS-1500PDZ · Traditional | Litecure, LLC | 03/29/2013SE |
| K121508 | Lightwalker at Lightwalker DT Lightwalker St-E Lightwalker St-NPDZ · Traditional | Fotona D.D. | 12/12/2012SE |
| K113843 | Freedom ND: Yag Laser SystemPDZ · Traditional | Lutronic Corporation | 09/27/2012SE |
More from Lutronic Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K150664 | NeoLasGEX · Traditional | 12/22/2015SE |
Questions and answers
When was The PL-1064 Laser System cleared by the FDA?
The PL-1064 Laser System (K120938) received a 510(k) decision of Substantially Equivalent on September 24, 2012, 186 days after the submission was received.
What is the product code of K120938?
The FDA product code is PDZ – Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, a Class II (moderate risk) device regulated under 21 CFR 878.4810.