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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00647529004258 | K210183 | 000 |
| 00647529003879 | K210183 | 000 |
| 00647529003862 | K210183 | 000 |
| 00647529003855 | K210183 | 000 |
| 00647529003848 | K210183 | 000 |
| 00647529003831 | K210183 | 000 |
| 00647529003633 | K210183 | 000 |
| 00647529003787 | K210183 | 000 |
| 00647529003770 | K210183 | 000 |
| 00647529003886 | K210183 | 000 |
| 00647529003893 | K210183 | 000 |
| 00647529003763 | K210183 | 000 |
| 00647529004340 | K210183 | 000 |
| 00647529003954 | K210183 | 000 |
| 00647529003947 | K210183 | 000 |
| 00647529003930 | K210183 | 000 |
| 00647529003923 | K210183 | 000 |
| 00647529003916 | K210183 | 000 |
| 00647529003909 | K210183 | 000 |
| 00647529003749 | K210183 | 000 |