Lightwalker at Lightwalker DT Lightwalker St-E Lightwalker St-N
FDA 510(k) K121508 · Fotona D.D.
510(k) numberK121508
Submission
- Device name
- Lightwalker at Lightwalker DT Lightwalker St-E Lightwalker St-N
- Applicant
- Fotona D.D.
Ljubljana, SI - Received
- May 21, 2012
- Decision date
- December 12, 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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| K093162 | Fidelis Plus III D, at Fidelis D, Powerlase at D / Fidelis Plus III, at Fidelis…GEX · Traditional | 01/22/2010SE |
| K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…GEX · Traditional | 06/29/2009SE |
| K083889 | Fotona QX Nd:Yag/Ktp Laser System FamilyGEX · Traditional | 04/23/2009SE |
| K083034 | Fotona XD-2 Diode Laser System, Model MD01-2FGEX · Traditional | 02/04/2009SE |
| K070355 | Fotona Fidelis III Er:Yag/Nd:Yag Laser System FamilyGEX · Traditional | 03/04/2008SE |
Questions and answers
When was Lightwalker at Lightwalker DT Lightwalker St-E Lightwalker St-N cleared by the FDA?
Lightwalker at Lightwalker DT Lightwalker St-E Lightwalker St-N (K121508) received a 510(k) decision of Substantially Equivalent on December 12, 2012, 205 days after the submission was received.
What is the product code of K121508?
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.