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

Allendale, NJ, US

Sharplan Lasers, Inc. appears in FDA device records in Allendale, NJ. FDA records list 78 510(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
78
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 78

FDA records hold 78 510(k) clearances for Sharplan Lasers, Inc. between 1986 and 1997. The busiest year on record is 1988, with 13. The most recent is 1997, with 6.

Clearances by year, as a table
510(k) clearance decisions for Sharplan Lasers, Inc., by decision year
YearClearances
19861
19873
198813
198912
19909
19914
19925
19933
19948
19956
19968
19976
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K973354SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)GEXSubstantially Equivalent
K972099SHARPLAN EPITOUCH RUBY LASER SYSTEMGEXSubstantially Equivalent
K971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)GEXSubstantially Equivalent
K971648SHARPLAN ERBIUM: YAG LASER (4020)GEXSubstantially Equivalent
K971743SHARPLAN CO2 SURGICAL LASER SYSTEMGEXSubstantially Equivalent
K962446SHARPLAN RUBY LASER SYSTEMGEXSubstantially Equivalent
K963229SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERSGEXSubstantially Equivalent
K961935SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNERGEXSubstantially Equivalent
K962974SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713)GEXSubstantially Equivalent
K961279SHARPLAN LASERS, INC. RUBY LASER SYSTEMGEXSubstantially Equivalent
K960820SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNERGEXSubstantially Equivalent
K960040SHARPLAN ULTRA LAPAROSCOPIC HANDPIECELFLSubstantially Equivalent
K960521SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNERGEXSubstantially Equivalent
K955621SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNERGEXSubstantially Equivalent
K952277SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEMGEXSubstantially Equivalent
K953794SHARPLAN LASERS, INC. SURGICAL DIODE LASERGEXSubstantially Equivalent
K951165SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEMGEXSubstantially Equivalent
K951204SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATORGEXSubstantially Equivalent
K945796SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEMITXSubstantially Equivalent
K950725SHARPLAN MODEL 1015 CO2 LASERGEXSubstantially Equivalent
K933918SHARPLAN MODEL 1080S CO2 SURGICAL LASERGEXSubstantially Equivalent
K942740SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEMGCJSubstantially Equivalent
K941312SHARPLAN SWIFTLASE 765/766/767 FLASHSCANGEXSubstantially Equivalent
K936109SHARPLAN MODEL 1120 CO2 SURGICAL LASERGEXSubstantially Equivalent
K935563SHARPLAN SURGICAL CO2 LASERS AND ACCESSORIESGEXSubstantially Equivalent
K926543SHARPLAN ND:YAG SURGICAL LASER, MODEL 3060 SHARPLASER 60GEXSubstantially Equivalent
K923605MODIFIED SHARPLAN 1041GEXSubstantially Equivalent
K934097I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERAGCJSubstantially Equivalent
K930582SHARPLAN SHARPLASE LATERAL ND:YAG FIBERGEXSubstantially Equivalent
K931978SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEMGEXSubstantially Equivalent
K920865SHARPLAN 2100,3000,SHARPLASER 65, 40GEXSubstantially Equivalent
K923855SHARPULSEGEXSubstantially Equivalent
K921146SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40GEXSubstantially Equivalent
K921596SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECEGEXSubstantially Equivalent
K913848SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATORMGISubstantially Equivalent
K914455SHARPLAN MODELS 100 SERIES C02 LASERS/ACCESSORIESGEXSubstantially Equivalent
K914089SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAGGEXSubstantially Equivalent
K913037SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERSGEXSubstantially Equivalent
K912792SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASERGEXSubstantially Equivalent
K910051SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65GEXSubstantially Equivalent
K903230SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075GEXSubstantially Equivalent
K900345SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERYGEXSubstantially Equivalent
K900346SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMYGEXSubstantially Equivalent
K900592SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASERGEXSubstantially Equivalent
K900076SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATORGEXSubstantially Equivalent
K900153SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEMGEXSubstantially Equivalent
K900077SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEMGEXSubstantially Equivalent
K896762SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMYGEXSubstantially Equivalent
K896847SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEMGEXSubstantially Equivalent
K895746SHARPLAN MODEL 710 MICROSPOTGEXSubstantially 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.

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