The following data is part of a premarket notification filed by Sheaumann Laser, Inc with the FDA for The Pl-1064 Laser System.
| Device ID | K120938 |
| 510k Number | K120938 |
| Device Name: | THE PL-1064 LASER SYSTEM |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | SHEAUMANN LASER, INC 189 WINDING OAKS LANE Oviedo, FL 32765 |
| Contact | Timothy J Shea |
| Correspondent | Timothy J Shea SHEAUMANN LASER, INC 189 WINDING OAKS LANE Oviedo, FL 32765 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-22 |
| Decision Date | 2012-09-24 |
| Summary: | summary |