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FDA PRODUCT CODE · CLASS II

PKT — Laser For Disruption Of Adipocyte Cells For Aesthetic Use

Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.5400
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining✓ GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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