Erchonia Ml Scanner (Mls)

by Erchonia Medical De Novo

Active United States

De Novo DEN090008

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA De NovoDENG De Novo granted · Post-NSE	NumberDEN090008	Date24 Aug 2010Decided	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA De Novo Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

De Novo

De Novo Number: DEN090008
FDA Product Code: OLI

Device Class: Class II
Regulation: 21 CFR Part 878.5400
Advisory Committee: General, Plastic Surgery
FDA Decision: DENG De Novo granted

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