$MFST 510(k) Premarket Notification

Device Classification Name: Lamp, Infrared, Therapeutic Heating
510(K) Number: K152461
Device Name: The Time Machine Series Lasers
Applicant: MEDICAL LASERS MANUFACTURER INC., 4400 Route 9 South, Suite 1000, Freehold, NJ 07728
Applicant Contact: Bruce Schoengood
Correspondent: MDI CONSULTANTS, INC., 55 Northern Boulevard, Suite 200, Great Neck, NY 11021
Correspondent Contact: Jigar Shah
Regulation Number: 890.5500
Classification Product Code: ILY
Date Received: 08/28/2015
Decision Date: 07/08/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
510k Review Panel: General & Plastic Surgery
Type: Traditional
Reviewed By Third Party: No
Combination Product: No

https://www.accessdata.fda.gov/scripts/cdrh/c...ID=K152461

Page Last Updated: 07/11/2016