LASER HELMET

Laser, Comb, Hair

THERADOME INC.

The following data is part of a premarket notification filed by Theradome Inc. with the FDA for Laser Helmet.

Pre-market Notification Details

• Device ID: K113097
• 510k Number: K113097
• Device Name: LASER HELMET
• Classification: Laser, Comb, Hair
• Applicant: THERADOME INC. 1001 BEAR ISLAND RD, SUITE 136 Summerville, SC 29483
• Contact: Larry Petersen
• Correspondent: Larry Petersen; THERADOME INC. 1001 BEAR ISLAND RD, SUITE 136 Summerville, SC 29483
• Product Code: OAP
• CFR Regulation Number: 890.5500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-19
• Decision Date: 2012-03-02
• Summary: summary