THE PL-1064 LASER SYSTEM— 510(k) K120938

Substantially Equivalent

Sheaumann Laser, Inc.

FDA 510(k) clearance K120938 for THE PL-1064 LASER SYSTEM, Substantially Equivalent on 2012-09-24. Applicant: Sheaumann Laser, Inc.. Device class: 2.

Clearance details

Applicant: Sheaumann Laser, Inc.
Product code: Code PDZ
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2012-03-22
Decision date: 2012-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oviedo, FL, US

Download summary PDF View on FDA.gov ↗

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