The following data is part of a premarket notification filed by Sharplight Technologies Ltd. with the FDA for Rapid Family.
| Device ID | K173169 |
| 510k Number | K173169 |
| Device Name: | Rapid Family |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SharpLight Technologies Ltd. 33 Lazarov St. Rishon Le Zion, IL 7565435 |
| Contact | Ilan Sharon |
| Correspondent | Ilan Sharon Ilan Sharon A 109 Neot Golf Caesarea, IL |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110240134 | K173169 | 000 |
| 07290110240127 | K173169 | 000 |
| 07290110240110 | K173169 | 000 |
| 07290110240073 | K173169 | 000 |
| 07290110240059 | K173169 | 000 |