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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sharplan Lasers, Inc. — Predicate Candidate Screening

78 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

77 daysmedian FDA review time
207 days90th percentile
78clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973354SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)Sharplan Lasers, Inc.1997-12-04900
K972099SHARPLAN EPITOUCH RUBY LASER SYSTEMSharplan Lasers, Inc.1997-08-27840
K971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)Sharplan Lasers, Inc.1997-08-18900
K971648SHARPLAN ERBIUM: YAG LASER (4020)Sharplan Lasers, Inc.1997-07-23790
K971743SHARPLAN CO2 SURGICAL LASER SYSTEMSharplan Lasers, Inc.1997-07-18670
K962446SHARPLAN RUBY LASER SYSTEMSharplan Lasers, Inc.1997-03-072560
K963229SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERSSharplan Lasers, Inc.1996-11-05780
K961935SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNERSharplan Lasers, Inc.1996-11-011650
K962974SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713)Sharplan Lasers, Inc.1996-08-21210
K961279SHARPLAN LASERS, INC. RUBY LASER SYSTEMSharplan Lasers, Inc.1996-06-18760
K960820SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNERSharplan Lasers, Inc.1996-05-10710
K960040SHARPLAN ULTRA LAPAROSCOPIC HANDPIECESharplan Lasers, Inc.1996-04-291180
K960521SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNERSharplan Lasers, Inc.1996-04-26810
K955621SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNERSharplan Lasers, Inc.1996-02-27780
K952277SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEMSharplan Lasers, Inc.1995-11-161850
K953794SHARPLAN LASERS, INC. SURGICAL DIODE LASERSharplan Lasers, Inc.1995-11-14920
K951165SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEMSharplan Lasers, Inc.1995-06-12900
K951204SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATORSharplan Lasers, Inc.1995-06-01760
K945796SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEMSharplan Lasers, Inc.1995-05-241770
K950725SHARPLAN MODEL 1015 CO2 LASERSharplan Lasers, Inc.1995-04-06490
K933918SHARPLAN MODEL 1080S CO2 SURGICAL LASERSharplan Lasers, Inc.1994-08-253800
K942740SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEMSharplan Lasers, Inc.1994-08-23740
K941312SHARPLAN SWIFTLASE 765/766/767 FLASHSCANSharplan Lasers, Inc.1994-06-301040
K935563SHARPLAN SURGICAL CO2 LASERS AND ACCESSORIESSharplan Lasers, Inc.1994-05-171810
K936109SHARPLAN MODEL 1120 CO2 SURGICAL LASERSharplan Lasers, Inc.1994-05-171410
K926543SHARPLAN ND:YAG SURGICAL LASER, MODEL 3060 SHARPLASER 60Sharplan Lasers, Inc.1994-03-094330
K923605MODIFIED SHARPLAN 1041Sharplan Lasers, Inc.1994-02-235930
K934097I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERASharplan Lasers, Inc.1994-02-071680
K930582SHARPLAN SHARPLASE LATERAL ND:YAG FIBERSharplan Lasers, Inc.1993-11-022710
K931978SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEMSharplan Lasers, Inc.1993-09-231540
K920865SHARPLAN 2100,3000,SHARPLASER 65, 40Sharplan Lasers, Inc.1993-08-025240
K923855SHARPULSESharplan Lasers, Inc.1992-12-241670
K921146SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40Sharplan Lasers, Inc.1992-06-08900
K921596SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECESharplan Lasers, Inc.1992-05-13400
K913848SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATORSharplan Lasers, Inc.1992-03-272130
K914455SHARPLAN MODELS 100 SERIES C02 LASERS/ACCESSORIESSharplan Lasers, Inc.1992-03-111560
K914089SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAGSharplan Lasers, Inc.1991-12-06860
K913037SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERSSharplan Lasers, Inc.1991-09-06590
K912792SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASERSharplan Lasers, Inc.1991-08-29650
K910051SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65Sharplan Lasers, Inc.1991-04-08910
K903230SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075Sharplan Lasers, Inc.1990-10-11800
K900345SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERYSharplan Lasers, Inc.1990-04-10770
K900346SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMYSharplan Lasers, Inc.1990-04-04710
K900592SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASERSharplan Lasers, Inc.1990-03-27480
K900076SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATORSharplan Lasers, Inc.1990-03-22770
K900153SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEMSharplan Lasers, Inc.1990-03-19670
K900077SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEMSharplan Lasers, Inc.1990-03-06610
K896762SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMYSharplan Lasers, Inc.1990-02-16770
K896847SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEMSharplan Lasers, Inc.1990-01-24500
K895746SHARPLAN MODEL 710 MICROSPOTSharplan Lasers, Inc.1989-10-0590

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda