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Cutera Tabletop Aesthetic Product

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042165

by Cutera, Inc.

Identifiers

510(k) Number
K042165 FDA 510(k)
FDA Product Code
ILY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5500 FDA 510(k)
Regulation Number
890.5500 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Cutera Tabletop Aesthetic Product by Cutera, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cutera, Inc.

Sources (1)

  • FDA 510(k) K042165 24 fields · synced Jun 18, 2026