MEDILASER MIC MODEL MEL 440-C - Medilaser Mic Model Mel 440-C

FDA 510(k)

Class II (US FDA 510(k))

510(k) K852121

Identifiers

510(k) Number: K852121 FDA 510(k)
FDA Product Code: GEX FDA 510(k)
Models / Variants: Medilaser Mic Model Mel 440-C FDA 510(k)
30w 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)

MEDILASER MIC MODEL MEL 440-C - Medilaser Mic Model Mel 440-C by Mochida Pharmaceutical Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 2 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K852121	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Mochida Pharmaceutical Co., Ltd.

Sources (1)

FDA 510(k) K852121 24 fields · synced Jun 18, 2026