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 |