The following data is part of a premarket notification filed by Laserscope with the FDA for Aura Dye Laser System (adls).
| Device ID | K984424 |
| 510k Number | K984424 |
| Device Name: | AURA DYE LASER SYSTEM (ADLS) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Contact | Paul H Hardiman |
| Correspondent | Paul H Hardiman LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-11 |
| Decision Date | 1999-03-05 |
| Summary: | summary |