The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Twilite, Twilite White.
| Device ID | K003385 |
| 510k Number | K003385 |
| Device Name: | TWILITE, TWILITE WHITE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673 |
| Contact | Ioana M Rizoiu |
| Correspondent | Ioana M Rizoiu BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-31 |
| Decision Date | 2001-01-25 |