510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Biolitec, Inc.

East Longmeadow, MA, US

Biolitec, Inc. appears in FDA device records in East Longmeadow, MA. FDA records list 28 510(k) clearances between and , one PMA record and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
28
PMA records
1
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 28 510(k) clearances for Biolitec, Inc. between 2001 and 2012. The busiest year on record is 2008, with 6. The most recent is 2012, with 1.

Clearances by year, as a table
510(k) clearance decisions for Biolitec, Inc., by decision year
YearClearances
20013
20023
20032
20042
20051
20061
20072
20086
20092
20103
20112
20121
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K112013EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASERGEXSubstantially Equivalent
K112253CERALAS 147NM DIODE LASER SYSTEMGEXSubstantially Equivalent
K110080RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEMGEXSubstantially Equivalent
K102755CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASERGEXSubstantially Equivalent
K101712ENDOVASCULAR LAER VEIN SYSTEM KITGEXSubstantially Equivalent
K100726CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NMGEXSubstantially Equivalent
K090164CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASERGEXSubstantially Equivalent
K083682180W CERELAS D 980NM DIODE LASER, MODEL D180GEXSubstantially Equivalent
K08222515W CERALAS D 1470NM DIODE LASER, MODEL D1470GEXSubstantially Equivalent
K082263CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980GEXSubstantially Equivalent
K081015CERALAS D 980NM DIODE LASER, MODELS D15 AND D25GEXSubstantially Equivalent
K07268250W CERALAS D 1950NM DIODE LASERGEXSubstantially Equivalent
K07306315W CERALAS D 1470NM DIODE LASERGEXSubstantially Equivalent
K072779CERALAS D 980NM DIODE LASER, MODELS D15 AND D25GEXSubstantially Equivalent
K072106150W CERALAS D 980NM DIODE LASERGEXSubstantially Equivalent
K071295100W CERALAS D 980NM DIODE LASERGEXSubstantially Equivalent
K060050MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEMGEXSubstantially Equivalent
K050824100W CERALAS D 980 LASER SYSTEM, MODEL D100GEXSubstantially Equivalent
K032864CERALAS D 810 DIODE LASER SYSTEM, MODEL D15GEXSubstantially Equivalent
K032863CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50GEXSubstantially Equivalent
K030700CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KITGEXSubstantially Equivalent
K024088CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25GEXSubstantially Equivalent
K013691CERALAS D DIODE LASER SYSTEM, MODEL # D50GEXSubstantially Equivalent
K020835CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60GEXSubstantially Equivalent
K020099MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECEGEXSubstantially Equivalent
K013193MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECEGEXSubstantially Equivalent
K010804MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPSGEXSubstantially Equivalent
K010689MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UMGEXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Biolitec, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Biolitec, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

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