The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Indigo Diffuser-tip Fiberoptic With Temperature Sensing Option, Model Lf001.
| Device ID | K003953 |
| 510k Number | K003953 |
| Device Name: | INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Jackie Hughes |
| Correspondent | Jackie 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 |