The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Indigo Optima Laser System.
| Device ID | K013493 |
| 510k Number | K013493 |
| Device Name: | INDIGO OPTIMA LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 |
| Contact | Linda Hill |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2001-12-13 |
| Summary: | summary |