The following data is part of a premarket notification filed by A.r.c. Laser Ag with the FDA for A.r.c. Low Bubble Turbo Needle, Model We0106.5.
| Device ID | K002986 |
| 510k Number | K002986 |
| Device Name: | A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 |
| Classification | Unit, Phacofragmentation |
| Applicant | A.R.C. LASER AG 2417 SOUTH 3850 WEST Salt Lake City, UT 84120 |
| Contact | Daniel Hoefer |
| Correspondent | Daniel Hoefer A.R.C. LASER AG 2417 SOUTH 3850 WEST Salt Lake City, UT 84120 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-25 |
| Decision Date | 2000-11-29 |