The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Indigo Laseroptic Treatment System.
| Device ID | K003952 |
| 510k Number | K003952 |
| Device Name: | INDIGO LASEROPTIC TREATMENT SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Jacquelyn A Hughes |
| Correspondent | Jacquelyn A Hughes ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-21 |
| Decision Date | 2001-03-16 |