Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cooper Lasersonics, Inc. — Predicate Candidate Screening
54 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
156 days90th percentile
54clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880809 | ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU | Cooper Lasersonics, Inc. | 1988-04-18 | 52 | 0 |
| K880807 | ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU | Cooper Lasersonics, Inc. | 1988-04-18 | 52 | 0 |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | 1988-04-18 | 77 | 0 |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | 1988-04-18 | 77 | 0 |
| K880808 | ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU | Cooper Lasersonics, Inc. | 1988-04-18 | 52 | 0 |
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | 1988-04-18 | 77 | 0 |
| K880171 | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | Cooper Lasersonics, Inc. | 1988-04-11 | 87 | 0 |
| K880170 | MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Cooper Lasersonics, Inc. | 1988-03-24 | 69 | 0 |
| K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | Cooper Lasersonics, Inc. | 1988-03-24 | 69 | 0 |
| K880172 | MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. | Cooper Lasersonics, Inc. | 1988-03-11 | 56 | 0 |
| K875115 | INFRAGUIDE(TM) | Cooper Lasersonics, Inc. | 1988-02-26 | 74 | 0 |
| K873790 | MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY | Cooper Lasersonics, Inc. | 1988-01-22 | 126 | 0 |
| K873443 | ULTRASPOT MICROMANIPULATOR | Cooper Lasersonics, Inc. | 1988-01-06 | 132 | 0 |
| K871220 | MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. | Cooper Lasersonics, Inc. | 1987-07-16 | 118 | 0 |
| K864983 | CUSA SYSTEM 200 MACRO-DISSECTOR | Cooper Lasersonics, Inc. | 1987-06-23 | 183 | 0 |
| K864563 | MODEL LS 840, CO2 LASER | Cooper Lasersonics, Inc. | 1987-04-09 | 141 | 0 |
| K864562 | MODEL LS 860, CO2 LASER | Cooper Lasersonics, Inc. | 1987-04-09 | 141 | 0 |
| K864960 | TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. | Cooper Lasersonics, Inc. | 1987-02-10 | 50 | 0 |
| K862835 | CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE | Cooper Lasersonics, Inc. | 1987-02-05 | 195 | 0 |
| K864413 | MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE | Cooper Lasersonics, Inc. | 1986-12-09 | 29 | 0 |
| K863086 | SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG | Cooper Lasersonics, Inc. | 1986-12-04 | 114 | 0 |
| K863361 | MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA | Cooper Lasersonics, Inc. | 1986-11-24 | 83 | 0 |
| K863183 | ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY | Cooper Lasersonics, Inc. | 1986-10-24 | 66 | 0 |
| K861904 | HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE | Cooper Lasersonics, Inc. | 1986-10-16 | 153 | 0 |
| K860831 | MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) | Cooper Lasersonics, Inc. | 1986-10-02 | 211 | 0 |
| K863433 | MODEL 8900 ND:YAG LASER | Cooper Lasersonics, Inc. | 1986-09-17 | 13 | 0 |
| K861955 | CONTACT TIPS | Cooper Lasersonics, Inc. | 1986-08-14 | 86 | 0 |
| K862456 | ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION | Cooper Lasersonics, Inc. | 1986-08-12 | 46 | 0 |
| K853117 | COOPER LASER SONICS ND: YAG LASER, MODEL 8008 | Cooper Lasersonics, Inc. | 1986-08-12 | 383 | 0 |
| K862698 | 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION | Cooper Lasersonics, Inc. | 1986-08-05 | 21 | 0 |
| K861903 | #6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL | Cooper Lasersonics, Inc. | 1986-06-20 | 35 | 0 |
| K860822 | LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35 | Cooper Lasersonics, Inc. | 1986-04-17 | 44 | 0 |
| K855246 | AURORA M MEDICAL DYE LASER | Cooper Lasersonics, Inc. | 1986-03-21 | 91 | 0 |
| K853143 | COOPER LASER SONICS CUSA MODEL 200 | Cooper Lasersonics, Inc. | 1985-10-16 | 79 | 0 |
| K851000 | COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY | Cooper Lasersonics, Inc. | 1985-08-14 | 156 | 0 |
| K852252 | 870 SURGICAL SYS CONTROL PULSE MODIFICATION | Cooper Lasersonics, Inc. | 1985-06-27 | 33 | 0 |
| K844440 | MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL | Cooper Lasersonics, Inc. | 1985-05-09 | 174 | 0 |
| K850728 | MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE | Cooper Lasersonics, Inc. | 1985-04-08 | 45 | 0 |
| K850779 | MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT | Cooper Lasersonics, Inc. | 1985-04-02 | 35 | 0 |
| K850432 | LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS- | Cooper Lasersonics, Inc. | 1985-02-15 | 11 | 0 |
| K844209 | ARGON/KRYPTON LASER SYSTEM 8500 | Cooper Lasersonics, Inc. | 1985-02-06 | 98 | 0 |
| K844668 | MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE | Cooper Lasersonics, Inc. | 1985-01-03 | 34 | 0 |
| K842703 | ND-YAG LASER 8000 NEUROSURGERY APPLICA | Cooper Lasersonics, Inc. | 1984-10-31 | 112 | 0 |
| K843240 | LASER FOR GENITOURINARY APPLIC. 4000 | Cooper Lasersonics, Inc. | 1984-10-02 | 41 | 0 |
| K841869 | COOPER LASERSONICS, 8000 ND.YAGLASER | Cooper Lasersonics, Inc. | 1984-08-08 | 96 | 0 |
| K842581 | CAVI-MED | Cooper Lasersonics, Inc. | 1984-08-03 | 31 | 0 |
| K842412 | MODEL 4000 MD-YAG LASER FOR MALIGNANT | Cooper Lasersonics, Inc. | 1984-06-26 | 7 | 0 |
| K841793 | COOPER LASERSONICS ND:YAG LASER 8000 | Cooper Lasersonics, Inc. | 1984-06-07 | 38 | 0 |
| K840142 | YAG LASER 8000 - LOWER GI APPLICAT | Cooper Lasersonics, Inc. | 1984-05-18 | 133 | 0 |
| K840145 | MONITOR CO2 LASER SURGICAL SYSTEM | Cooper Lasersonics, Inc. | 1984-04-25 | 103 | 0 |
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