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

Alameda, CA, US

XINTEC CORPORATION appears in FDA device records in Alameda, CA. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. 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
26
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 26 510(k) clearances for Xintec Corporation between 1990 and 2010. The busiest year on record is 1995, with 5. The most recent is 2010, with 1.

Clearances by year, as a table
510(k) clearance decisions for Xintec Corporation, by decision year
YearClearances
19902
19912
19923
19933
19943
19955
19962
19972
19982
19991
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K082230VECTRA PLUS LASER SYSTEM AND ACCESSORIESGEXSubstantially Equivalent
K990914POLARIS DIODE LASER SYSTEM AND ACCESSORIESGEXSubstantially Equivalent
K981627PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)GEXSubstantially Equivalent
K981350ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIESGEXSubstantially Equivalent
K971912PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIESGEXSubstantially Equivalent
K971065DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIESGEXSubstantially Equivalent
K951935PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIESGEXSubstantially Equivalent
K951876PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIESGEXSubstantially Equivalent
K951910ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIESGEXSubstantially Equivalent
K951760OPTILITE VIII LASER SURGERY ACCESSORIESGEXSubstantially Equivalent
K945181GENERA 100 SURGICAL SYSTEMGEXSubstantially Equivalent
K944965OPTILITE VI FIBEROPTIC ACCESSORIESGEXSubstantially Equivalent
K944704OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIESGEXSubstantially Equivalent
K944749OPTICA 100 SUPERPULSED LASER SYSTEMGEXSubstantially Equivalent
K944474OPTILITE V FIBEROPTIC ACCESSORIESGEXSubstantially Equivalent
K942759OPTICON(TM) CONNECTOR ADAPTER IIGEXSubstantially Equivalent
K923599OPTILITE FIBEROPTIC DELIVERY SYSTEMSGEXSubstantially Equivalent
K930159OPTICON(TM) CONNECTOR ADAPTERGEXSubstantially Equivalent
K924166OPTILINK(TM) LPM (LASER POWER MODULATOR)GEXSubstantially Equivalent
K914678ODYSSEY HO:YAG SURGICAL LASER SYSTEMGEXSubstantially Equivalent
K914679PRODIGY ND:YAG SURGICAL LASER SYSTEMGEXSubstantially Equivalent
K913839OPTICA 25 ND:YAG DENTAL LASER SYSTEMGEXSubstantially Equivalent
K912703OPTICA 60 ND;YAG SURGICAL LASER SYSTEMGEXSubstantially Equivalent
K910114OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCEGEXSubstantially Equivalent
K902871OPTILITE FIBEROPTIC DELIVERY SYSTEMSGEXSubstantially Equivalent
K901710OPTICA 120 ND:YAG SURGICAL LASER SYSTEMGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Xintec Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29388892938889XINTEC CORPORATION1660 SOUTH LOOP ROAD, ALAMEDA, CA 94502 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-0162-2020OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.Class IIITerminated
Z-2866-2017OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards.Class IITerminated

Verification record

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