The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Micromanipulator.
| Device ID | K924457 | 
| 510k Number | K924457 | 
| Device Name: | MICROMANIPULATOR | 
| Classification | Powered Laser Surgical Instrument | 
| Applicant | LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 | 
| Contact | Lisa A Ares | 
| Correspondent | Lisa A Ares LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 | 
| Product Code | GEX | 
| CFR Regulation Number | 878.4810 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1992-09-02 | 
| Decision Date | 1993-05-07 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MICROMANIPULATOR  85308513  4180533 Live/Registered | The Micromanipulator Co., Inc. 2011-04-29 | 
|  MICROMANIPULATOR  77134042  not registered Dead/Abandoned | The Micromanipulator Co., Inc. 2007-03-19 |