ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM— 510(k) K121515

Name: FDA 510(k) clearance K121515
Creator: U.S. Food and Drug Administration
Published: 2012-06-05

Substantially Equivalent

Solta Medical, Inc.

FDA 510(k) clearance K121515 for ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM, Substantially Equivalent on 2012-06-05. Applicant: Solta Medical, Inc.. Device class: 2.

Clearance details

Applicant: Solta Medical, Inc.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2012-05-22
Decision date: 2012-06-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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