The following data is part of a premarket notification filed by Energy Life Systems Corp. with the FDA for Urotek Laser Catheter.
| Device ID | K945560 |
| 510k Number | K945560 |
| Device Name: | UROTEK LASER CATHETER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ENERGY LIFE SYSTEMS CORP. 3303 HARBOR BLVD., UNIT D-13 Costa Mesa, CA 92626 |
| Contact | Hany Hussein |
| Correspondent | Hany Hussein ENERGY LIFE SYSTEMS CORP. 3303 HARBOR BLVD., UNIT D-13 Costa Mesa, CA 92626 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-31 |
| Decision Date | 1995-01-18 |