The following data is part of a premarket notification filed by Jeisys Medical, Inc. with the FDA for P-nain System.
| Device ID | K072833 |
| 510k Number | K072833 |
| Device Name: | P-NAIN SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | JEISYS MEDICAL, INC. 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls JEISYS MEDICAL, INC. 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-03 |
| Decision Date | 2008-01-24 |