510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ceram Optec, Inc.

East Longmeadow, MA, US

Ceram Optec, Inc. appears in FDA device records in East Longmeadow, MA. FDA records list 30 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
30
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 30 510(k) clearances for Ceram Optec, Inc. between 1992 and 2000. The busiest year on record is 1994, with 8. The most recent is 2000, with 4.

Clearances by year, as a table
510(k) clearance decisions for Ceram Optec, Inc., by decision year
YearClearances
19921
19931
19948
19953
19963
19972
19984
19994
20004
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K002296CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15GEXSubstantially Equivalent
K001975CERALAS D10 810NM LASER, MODEL CERALAS D10-60GEXSubstantially Equivalent
K993911CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50GEXSubstantially Equivalent
K993828CERALAS D10 810NM DIODE LASERGEXSubstantially Equivalent
K993002CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15GEXSubstantially Equivalent
K992773CERALAS D10 810NM DIODE LASERGEXSubstantially Equivalent
K991891CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15GEXSubstantially Equivalent
K983950CERALAS DIODE LASER SYSTEM (MODEL H)GEXSubstantially Equivalent
K983058CERALAS D LASER SYSTEM, MODEL # CERALAS D15GEXSubstantially Equivalent
K980389MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLESGEXSubstantially Equivalent
K981126CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3GEXSubstantially Equivalent
K980838REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEMGEXSubstantially Equivalent
K964751CERALAS DIODE LASER SYSTEM (CERALAS D2)HQFSubstantially Equivalent
K964497CERALAS DIODE LASER SYSTEM (CERALAS D15)GEXSubstantially Equivalent
K962948CERALAS G ND;YAG LASER SYSTEM (CERALAS G)GEXSubstantially Equivalent
K953851CERALAS F ND:YAG LASER SYSTEMGEXSubstantially Equivalent
K954834CERALAS G FREQUENCY DOUBLED ND;YAG LASER SYSTEMGEXSubstantially Equivalent
K952772MEGABEAM ENDO-ENT PROBEGEXSubstantially Equivalent
K951775CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50)GEXSubstantially Equivalent
K952340MEGABEAM ASPIRATING ENDOCULAR PROBEGEXSubstantially Equivalent
K943527MEGABEAM LATERAL FIREGEXSubstantially Equivalent
K943526MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEMGEXSubstantially Equivalent
K943445MEGABEAM FIBER OPTIC DELIVERY SYSTEMGEXSubstantially Equivalent
K943444MEGABEAM LATERAL FIREGEXSubstantially Equivalent
K942182MEGABEAM DENTAL FIBERGEXSubstantially Equivalent
K935747MEGABEAM ENDOCULAR PROBEHQFSubstantially Equivalent
K924258MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYSTGEXSubstantially Equivalent
K934008MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTGEXSubstantially Equivalent
K923543MISHLJSubstantially Equivalent
K923953MEGABEAMGEXSubstantially 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

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