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Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172193

by Alma Lasers, Inc.

Identifiers

510(k) Number
K172193 FDA 510(k)
FDA Product Code
GEX 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)

Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology … by Alma Lasers, Inc. — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alma Lasers, Inc.

Sources (1)

  • FDA 510(k) K172193 24 fields · synced Jun 18, 2026