The following data is part of a premarket notification filed by W.o.m. World Of Medicine Ag with the FDA for W.o.m. Laser U100plus.
| Device ID | K032023 |
| 510k Number | K032023 |
| Device Name: | W.O.M. LASER U100PLUS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | W.O.M. WORLD OF MEDICINE AG 320 NORTH COLUMBUS ST. Alexandria, VA 22314 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab W.O.M. WORLD OF MEDICINE AG 320 NORTH COLUMBUS ST. Alexandria, VA 22314 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-30 |
| Decision Date | 2003-10-01 |
| Summary: | summary |