The following data is part of a premarket notification filed by Innovaquartz Llc with the FDA for Proflex Laser Fibers.
| Device ID | K180140 |
| 510k Number | K180140 |
| Device Name: | ProFlex Laser Fibers |
| Classification | Powered Laser Surgical Instrument |
| Applicant | InnovaQuartz LLC 23030 North 15th Ave Phoenix, AZ 85027 -1315 |
| Contact | Stephen E Griffin |
| Correspondent | Stephen E Griffin InnovaQuartz LLC 23030 North 15th Ave Phoenix, AZ 85027 -1315 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-18 |
| Decision Date | 2018-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816959021863 | K180140 | 000 |
| 00816959021726 | K180140 | 000 |
| 00816959021702 | K180140 | 000 |
| 00816959021689 | K180140 | 000 |
| 00816959021665 | K180140 | 000 |
| 00816959021658 | K180140 | 000 |
| 00816959021641 | K180140 | 000 |
| 00816959021634 | K180140 | 000 |
| 00816959021733 | K180140 | 000 |
| 00816959021719 | K180140 | 000 |
| 00816959021696 | K180140 | 000 |
| 00816959021740 | K180140 | 000 |
| 00816959021757 | K180140 | 000 |
| 00816959021856 | K180140 | 000 |
| 00816959021849 | K180140 | 000 |
| 00816959021832 | K180140 | 000 |
| 00816959021825 | K180140 | 000 |
| 00816959021818 | K180140 | 000 |
| 00816959021801 | K180140 | 000 |
| 00816959021795 | K180140 | 000 |
| 00816959021788 | K180140 | 000 |
| 00816959021771 | K180140 | 000 |
| 00816959021764 | K180140 | 000 |
| 00816959021672 | K180140 | 000 |