510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Biolase MG LLC

Foothill Ranch, CA, US

BIOLASE MG LLC appears in FDA device records in Foothill Ranch, CA. FDA records list 31 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
31
PMA records
0
Recall records
2
Registered establishments
2

FDA records under these names

1 name

FDA records resolved to Biolase MG LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Biolase Technology, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 31 510(k) clearances for Biolase MG LLC between 1995 and 2013. The busiest year on record is 2008, with 5. The most recent is 2013, with 3.

Clearances by year, as a table
510(k) clearance decisions for Biolase MG LLC, by decision year
YearClearances
19951
19981
19992
20001
20012
20022
20032
20042
20061
20071
20085
20095
20102
20121
20133
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K122368WATERLASE IPLUS ALL TISSUE LASERGEXSubstantially Equivalent
K130465EPIC 10SGEXSubstantially Equivalent
K121327DIOLASE 10SGEXSubstantially Equivalent
K121286EPIC 10GEXSubstantially Equivalent
K101658WATERLASE MD TURBO PLUS MODEL 7200XXXGEXSubstantially Equivalent
K093852EZLASE 3 LASER SYSTEMGEXSubstantially Equivalent
K091746WATERLASE MD, MODEL 7100102GEXSubstantially Equivalent
K083927WATERLASE MDGEXSubstantially Equivalent
K091922WATERLASE C100, MODEL 7100104GEXSubstantially Equivalent
K083595EZLASEILYSubstantially Equivalent
K090181WATERLASE MDGEXSubstantially Equivalent
K082938EZLASEGEXSubstantially Equivalent
K083069EZLASE 10WGEXSubstantially Equivalent
K081589WATERLASE, VERSION 3.0GEXSubstantially Equivalent
K071363WATERLASE AND WATERLASE MDGEXSubstantially Equivalent
K071734WATERLASE MD DERMGEXSubstantially Equivalent
K061898EZLASEGEXSubstantially Equivalent
K052354OCULASE MDGEXSubstantially Equivalent
K031140WATERLASEGEXSubstantially Equivalent
K030523WATERLASEGEXSubstantially Equivalent
K030539LASERSMILEGEXSubstantially Equivalent
K022803WATERLASE FOR APICOECTOMYMXFSubstantially Equivalent
K013908WATERLASE MILLENNIUMMXFSubstantially Equivalent
K012511WATERLASE MILLENNIUMMXFSubstantially Equivalent
K011041WATERLASE, MILLENNIUMGEXSubstantially Equivalent
K003385TWILITE, TWILITE WHITEGEXSubstantially Equivalent
K000290LAZERSMILE, LAZERWHITEEFWSubstantially Equivalent
K991994TWILIGHTGEXSubstantially Equivalent
K990219MODIFICATION OF MILLENNIUMMXFSubstantially Equivalent
K980585MILLENNIUMEFBSubstantially Equivalent
K950248LASERSPRAY(TM)GEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Biolase MG LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20277552027755BIOLASE MG LLC27042 Towne Centre Drive, Foothill Ranch, CA 92610 US2026
30171251613017125161BIOLASE MG LLC4225 Prado Road, Corona, CA 92880 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2263-2014WaterLase 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.Class IITerminated
Z-0543-05Waterlase 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.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain