The following data is part of a premarket notification filed by Fa International, Lp with the FDA for Ultraclear Fractional Laser System.
| Device ID | K210847 |
| 510k Number | K210847 |
| Device Name: | UltraClear Fractional Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FA International, LP 614 George Washington Highway Lincoln, RI 02865 |
| Contact | Sharon Timberlake |
| Correspondent | Sharon Timberlake Sharon Timberlake Consulting, LLC 27 Dunelm Road Bedford, MA 01730 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-22 |
| Decision Date | 2021-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850039149047 | K210847 | 000 |
| 00850039149030 | K210847 | 000 |
| 00850039149023 | K210847 | 000 |
| 00850039149016 | K210847 | 000 |
| 00850039149429 | K210847 | 000 |
| 00850039149009 | K210847 | 000 |