The following data is part of a premarket notification filed by Freedom Laser Therapy, Inc. with the FDA for Irestore.
Device ID | K151662 |
510k Number | K151662 |
Device Name: | IRestore |
Classification | Laser, Comb, Hair |
Applicant | Freedom Laser Therapy, Inc. 7815 Beverly Blvd., 3rd Floor Los Angeles, CA 90036 |
Contact | Craig Nabat |
Correspondent | Raymond R. Blanche NST Consulting, LLC 641 Shunpike Road, Suite 311 Chatham, NJ 07928 |
Product Code | OAP |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-19 |
Decision Date | 2016-01-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00859690003361 | K151662 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() IRESTORE 97678591 not registered Live/Pending |
Freedom Laser Therapy, Inc. 2022-11-15 |
![]() IRESTORE 97416953 not registered Live/Pending |
iRestore Stl. LLC 2022-05-18 |
![]() IRESTORE 87673902 not registered Dead/Abandoned |
Charles Komar & Sons, Inc 2017-11-06 |
![]() IRESTORE 87066690 5262367 Live/Registered |
Bossanova Systems, Inc. 2016-06-09 |
![]() IRESTORE 87023599 5239404 Live/Registered |
FREEDOM LASER THERAPY, INC. 2016-05-03 |
![]() IRESTORE 85861172 not registered Dead/Abandoned |
Sturgill, Patrick 2013-02-27 |
![]() IRESTORE 85237372 not registered Dead/Abandoned |
Nabat, Craig 2011-02-08 |
![]() IRESTORE 85237372 not registered Dead/Abandoned |
Chen, Mike Chung-Yang 2011-02-08 |
![]() IRESTORE 77821398 not registered Dead/Abandoned |
Chen, Mike Chung-Yang 2009-09-08 |
![]() IRESTORE 77821398 not registered Dead/Abandoned |
Nabat, Craig 2009-09-08 |