Cooper Lasersonics, Inc.
Orangeburg, NY, US
Cooper Lasersonics, Inc. appears in FDA device records in Orangeburg, NY. FDA records list 54 510(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
- 54
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 54FDA records hold 54 510(k) clearances for Cooper Lasersonics, Inc. between 1982 and 1988. The busiest year on record is 1986, with 14. The most recent is 1988, with 13.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 2 |
| 1983 | 2 |
| 1984 | 8 |
| 1985 | 9 |
| 1986 | 14 |
| 1987 | 6 |
| 1988 | 13 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K880809 | ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU | GEX | Substantially Equivalent | |
| K880808 | ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU | GEX | Substantially Equivalent | |
| K880807 | ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU | GEX | Substantially Equivalent | |
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | EWG | Substantially Equivalent | |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | EWG | Substantially Equivalent | |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | EWG | Substantially Equivalent | |
| K880171 | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | LNK | Substantially Equivalent | |
| K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | HHR | Substantially Equivalent | |
| K880170 | MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | LLO | Substantially Equivalent | |
| K880172 | MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. | LKW | Substantially Equivalent | |
| K875115 | INFRAGUIDE(TM) | GEX | Substantially Equivalent | |
| K873790 | MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY | GEX | Substantially Equivalent | |
| K873443 | ULTRASPOT MICROMANIPULATOR | GEX | Substantially Equivalent | |
| K871220 | MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. | HHR | Substantially Equivalent | |
| K864983 | CUSA SYSTEM 200 MACRO-DISSECTOR | LFL | Substantially Equivalent | |
| K864563 | MODEL LS 840, CO2 LASER | GEX | Substantially Equivalent for Some Indications | |
| K864562 | MODEL LS 860, CO2 LASER | GEX | Substantially Equivalent for Some Indications | |
| K864960 | TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. | GCQ | Substantially Equivalent | |
| K862835 | CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE | EOQ | Substantially Equivalent | |
| K864413 | MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE | KNS | Substantially Equivalent | |
| K863086 | SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG | GEX | Substantially Equivalent | |
| K863361 | MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA | HHR | Substantially Equivalent | |
| K863183 | ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY | GEX | Substantially Equivalent | |
| K861904 | HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE | KNS | Substantially Equivalent | |
| K860831 | MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) | GEX | Substantially Equivalent | |
| K863433 | MODEL 8900 ND:YAG LASER | GEX | Substantially Equivalent | |
| K861955 | CONTACT TIPS | LNK | Substantially Equivalent | |
| K862456 | ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION | HHR | Substantially Equivalent | |
| K853117 | COOPER LASER SONICS ND: YAG LASER, MODEL 8008 | GEX | Substantially Equivalent | |
| K862698 | 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION | LLO | Substantially Equivalent | |
| K861903 | #6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL | LNK | Substantially Equivalent | |
| K860822 | LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35 | FAJ | Substantially Equivalent | |
| K855246 | AURORA M MEDICAL DYE LASER | GEX | Substantially Equivalent | |
| K853143 | COOPER LASER SONICS CUSA MODEL 200 | LBK | Substantially Equivalent | |
| K851000 | COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY | GEX | Substantially Equivalent | |
| K852252 | 870 SURGICAL SYS CONTROL PULSE MODIFICATION | GEX | Substantially Equivalent | |
| K844440 | MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL | LKW | Substantially Equivalent | |
| K850728 | MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE | LNK | Substantially Equivalent | |
| K850779 | MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT | GEX | Substantially Equivalent | |
| K850432 | LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS- | LLO | Substantially Equivalent | |
| K844209 | ARGON/KRYPTON LASER SYSTEM 8500 | HQB | Substantially Equivalent | |
| K844668 | MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE | HQF | Substantially Equivalent | |
| K842703 | ND-YAG LASER 8000 NEUROSURGERY APPLICA | GEX | Substantially Equivalent | |
| K843240 | LASER FOR GENITOURINARY APPLIC. 4000 | LNK | Substantially Equivalent | |
| K841869 | COOPER LASERSONICS, 8000 ND.YAGLASER | LNK | Substantially Equivalent | |
| K842581 | CAVI-MED | ELC | Substantially Equivalent | |
| K842412 | MODEL 4000 MD-YAG LASER FOR MALIGNANT | HQF | Substantially Equivalent | |
| K841793 | COOPER LASERSONICS ND:YAG LASER 8000 | Substantially Equivalent | ||
| K840142 | YAG LASER 8000 - LOWER GI APPLICAT | LNK | Substantially Equivalent | |
| K840145 | MONITOR CO2 LASER SURGICAL SYSTEM | HQF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EOQBronchoscope (Flexible Or Rigid)
- FAJCystoscope And Accessories, Flexible/Rigid
- GCQEndoscope, Flexible
- LFLInstrument, Ultrasonic Surgical
- LNKLaser For Gastro-Urology Use
- EWGLaser, Ent Microsurgical Carbon-Dioxide
- LLOLaser, Neodymium:Yag, Pulmonary Surgery
- LKWLaser, Neurosurgical
- HQFLaser, Ophthalmic
- HHRLaser, Surgical, Gynecologic
- LBKNeurosurgical Ultrasonic Instruments
- HQBPhotocoagulator And Accessories
- GEXPowered Laser Surgical Instrument
- ELCScaler, Ultrasonic
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
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