The following data is part of a premarket notification filed by Lumen Development And Manufacturing, Inc. with the FDA for Twinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980 Dental Laser.
| Device ID | K072995 |
| 510k Number | K072995 |
| Device Name: | TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMEN DEVELOPMENT AND MANUFACTURING, INC. 532 WEST 8360 SOUTH Sandy, UT 84070 |
| Contact | Calvin D Ostler |
| Correspondent | Calvin D Ostler LUMEN DEVELOPMENT AND MANUFACTURING, INC. 532 WEST 8360 SOUTH Sandy, UT 84070 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-23 |
| Decision Date | 2007-12-18 |