The following data is part of a premarket notification filed by Epilady 2000 Llc with the FDA for Epilaser.
Device ID | K170970 |
510k Number | K170970 |
Device Name: | Epilaser |
Classification | Powered Laser Surgical Instrument |
Applicant | Epilady 2000 LLC 3 Hacharash St. Ind. Zone Hazor Haglilit, IL 1035102 |
Contact | Joseph Miller |
Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 -1109 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-31 |
Decision Date | 2017-09-01 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EPILASER 86395820 5428680 Live/Registered |
Epilady 2000 LLC 2014-09-16 |
![]() EPILASER 86052410 5448709 Live/Registered |
Epilady 2000 LLC 2013-08-30 |
![]() EPILASER 78122591 3234102 Dead/Cancelled |
EpiWorks, Inc. 2002-04-18 |
![]() EPILASER 74722809 2122098 Dead/Cancelled |
PALOMAR MEDICAL PRODUCTS, INC. 1995-08-30 |