LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N— 510(k) K121508
Substantially EquivalentFotona D.D.
FDA 510(k) clearance K121508 for LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N, Substantially Equivalent on 2012-12-12. Applicant: Fotona D.D.. Device class: 2.
Clearance details
- Applicant
- Fotona D.D.
- Product code
- Code PDZ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ljubljana, SI
Recent devices under product code PDZ
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- K101817 — LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N
Data sourced from openFDA. This site is unofficial and independent of the FDA.