Data / Medical devices / United States / Biolase MG LLC
Biolase MG LLC: FDA-registered device maker in Foothill Ranch, CA, United States, 12 510(k) clearances
Biolase MG LLC is registered with the FDA (registration 2027755) in Foothill Ranch, CA, United States. It lists 6 device types. The FDA files 12 510(k) clearances under its listings, the newest dated April 21, 2022. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2027755
- Address
- 27042 Towne Centre Drive Suite 270, Foothill Ranch, CA, United States, 92610
- Owner or operator
- MEGAGEN IMPLANT CO. LTD (9067358)
- Roles
- Specification developer
- First device listed
- January 2, 2025
- Registered through
- 2027
- Brand names listed
- EdgePro, Epic Hygiene, Epic Pro 940, Epic Pro 980, Epic S- Series, Epic X/10/T-Series, Powered Laser Surgical Instrument, WL Express and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drill, Bone, Powered | DZI | 2 | Specification developer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Specification developer | accessdata.fda.gov |
| Laser, Dental, Soft Tissue | NVK | 2 | Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Specification developer | accessdata.fda.gov |
| System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation | MXF | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2022 | K210183 | Waterlase iPLus | GEX | Substantially Equivalent | Biolase, Inc. | accessdata.fda.gov |
| December 22, 2021 | K213428 | EdgePro | NVK | Substantially Equivalent | Biolase, Inc. | accessdata.fda.gov |
| December 4, 2019 | K192430 | Epic 980 | GEX | Substantially Equivalent | Biolase, Inc. | accessdata.fda.gov |
| November 29, 2017 | K172771 | Epic Pro 940 | GEX | Substantially Equivalent | Biolase, Inc. | accessdata.fda.gov |
| January 11, 2017 | K163128 | Epic Pro | GEX | Substantially Equivalent | Biolase, Inc. | accessdata.fda.gov |
| July 28, 2016 | K161669 | Waterlase Express | GEX | Substantially Equivalent | Biolase, Inc. | accessdata.fda.gov |
| April 11, 2013 | K130465 | EPIC 10S | GEX | Substantially Equivalent | Biolase Technology, Inc. | accessdata.fda.gov |
| September 28, 2012 | K121286 | EPIC 10 | GEX | Substantially Equivalent | Biolase Technology, Inc. | accessdata.fda.gov |
| August 11, 2010 | K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | GEX | Substantially Equivalent | Biolase Technology, Inc. | accessdata.fda.gov |
| March 12, 2010 | K093852 | EZLASE 3 LASER SYSTEM | GEX | Substantially Equivalent | Biolase Technology, Inc. | accessdata.fda.gov |
| February 11, 2009 | K090181 | WATERLASE MD | GEX | Substantially Equivalent | Biolase Technology, Inc. | accessdata.fda.gov |
| July 7, 2004 | K031140 | WATERLASE | GEX | Substantially Equivalent | Biolase Technology, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 12, 2014 | 68870 | Class II | Terminated | WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463. | Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure screen, the air setting will change to 1% and OFF. | accessdata.fda.gov |
| January 17, 2005 | 31106 | Not yet classified | Terminated | Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive. | Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Laser, Dental, Soft Tissue
- All makers of Drill, Bone, Powered
Updated April 21, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.