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FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER - Moo1-14f

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090126

by Fotona D.D.

Identifiers

510(k) Number
K090126 FDA 510(k)
FDA Product Code
GEX FDA 510(k)
Models / Variants
Moo1-14f FDA 510(k)
Moo1-14f FDA 510(k)
Moo1-14f FDA 510(k)
2 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER - Moo1-14f by Fotona D.D. — Class II — FDA_510K — listed in FDA 510(k) — 4…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fotona D.D.

Sources (1)

  • FDA 510(k) K090126 24 fields · synced Jun 18, 2026