The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for W.o.m. Laser U100.
| Device ID | K011175 |
| 510k Number | K011175 |
| Device Name: | W.O.M. LASER U100 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH 91 TROWBRIDGE ST. # 21 Cambridge, MA 02138 |
| Contact | Michael Mcgrail |
| Correspondent | Michael Mcgrail W.O.M. WORLD OF MEDICINE, GMBH 91 TROWBRIDGE ST. # 21 Cambridge, MA 02138 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-17 |
| Decision Date | 2001-11-01 |