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Bare Laser Fiber (Dblf-40 +5 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K030959

by Laser Peripherals, Llc

Identifiers

510(k) Number
K030959 FDA 510(k)
FDA Product Code
GEX FDA 510(k)
Models / Variants
Dblf-40 FDA 510(k)
Dblf-60 FDA 510(k)
Dblf-60-1 FDA 510(k)
Dclf-600b FDA 510(k)
Dslf-60 FDA 510(k)
Dblf-100 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)

Bare Laser Fiber (Dblf-40 +5 more) by Laser Peripherals, Llc — Class II — FDA_510K — listed in FDA 510(k) — 6 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K030959 24 fields · synced Jun 18, 2026