The following data is part of a premarket notification filed by Biolase, Inc. with the FDA for Waterlase Iplus.
Device ID | K210183 |
510k Number | K210183 |
Device Name: | Waterlase IPLus |
Classification | Powered Laser Surgical Instrument |
Applicant | Biolase, Inc. 27042 Towne Centre Drive, Suite 270 Foothill Ranch, CA 92610 |
Contact | Katy Nennig |
Correspondent | Katy Nennig Biolase, Inc. 27042 Towne Centre Drive, Suite 270 Foothill Ranch, CA 92610 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-25 |
Decision Date | 2022-04-21 |