The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Dermalase.
| Device ID | K971459 |
| 510k Number | K971459 |
| Device Name: | DERMALASE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ENDO TECHNIC CORP. 981 CALLE AMANECER (MOVED FROM BOS/DO TO LA/DOS) San Clemente, CA 92673 -6212 |
| Contact | Andrew Kimmel |
| Correspondent | Andrew Kimmel ENDO TECHNIC CORP. 981 CALLE AMANECER (MOVED FROM BOS/DO TO LA/DOS) San Clemente, CA 92673 -6212 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-21 |
| Decision Date | 1997-07-18 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DERMALASE 85499185 not registered Dead/Abandoned |
BIOLASE, INC. 2011-12-19 |
![]() DERMALASE 75719807 not registered Dead/Abandoned |
ESC Medical Systems Ltd. 1999-10-30 |
![]() DERMALASE 74027165 1782079 Dead/Cancelled |
Derma-Lase Limited 1990-02-07 |