LASER HELMET— 510(k) K113097

Substantially Equivalent

Theradome, Inc.

FDA 510(k) clearance K113097 for LASER HELMET, Substantially Equivalent on 2012-03-02. Applicant: Theradome, Inc..

Clearance details

Applicant: Theradome, Inc.
Product code: Code OAP
Advisory panel: Physical Medicine
Date received: 2011-10-19
Decision date: 2012-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Summerville, SC, US

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