The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Epitouch Alexandrite Laser System (5000).
| Device ID | K973354 |
| 510k Number | K973354 |
| Device Name: | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHARPLAN LASERS, INC. 33 PLAN WAY Warwick, RI 02886 |
| Contact | George J Hattub |
| Correspondent | George J Hattub SHARPLAN LASERS, INC. 33 PLAN WAY Warwick, RI 02886 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-05 |
| Decision Date | 1997-12-04 |
| Summary: | summary |