FOTONA XP ND: YAG LASER SYSTEM— 510(k) K113702
Substantially EquivalentFotona D.D.
FDA 510(k) clearance K113702 for FOTONA XP ND: YAG LASER SYSTEM, Substantially Equivalent on 2012-03-28. 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
view allMore clearances from Fotona D.D.
view all- K143723 — SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
- K132806 — FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
- K121508 — LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
- K101306 — SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
- 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.