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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K141237

HARMONY LITE · Alma, Inc. · decided 2015-03-13 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Harmony Lite System 110V For Alma Inc (purple)1ALMA LASERS LTD.ONF17290110120938
Nir Handpiece (6cm) 1ALMA LASERS LTD.ILY ONF17290110121454
Nir Handpiece For Harmony Lite System (18cm)1ALMA LASERS LTD.ONF17290110120556
Nir Handpiece For Harmony Lite/ Spa Shr Pro (6cm)1ALMA LASERS LTD.ONF17290110120563