Cooper Lasersonics, Inc.: FDA filings under this applicant name
FDA lists 54 510(k) clearances under the applicant name “Cooper Lasersonics, Inc.” (first 1982, latest 1988), across 16 product codes in 8 review panels. Median 510(k) review time under this name: 77 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 18 | 18 |
| LNK | Laser For Gastro-Urology Use | 8 | 8 |
| HHR | Laser, Surgical, Gynecologic | 4 | 4 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 3 | 3 |
| HQF | Laser, Ophthalmic | 3 | 3 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 3 | 3 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
| LKW | Laser, Neurosurgical | 2 | 2 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
Plus 6 more product codes.
Review panels
- General and Plastic Surgery (19)
- Gastroenterology and Urology (12)
- Ear, Nose and Throat (4)
- Obstetrics and Gynecology (4)
- Ophthalmic (4)
- Anesthesiology (3)
- Neurology (3)
- Dental (1)
Most recent Cooper Lasersonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880809 | ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU | GEX | 1988-04-18 | 52 |
| K880808 | ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU | GEX | 1988-04-18 | 52 |
| K880807 | ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU | GEX | 1988-04-18 | 52 |
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | EWG | 1988-04-18 | 77 |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | EWG | 1988-04-18 | 77 |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | EWG | 1988-04-18 | 77 |
| K880171 | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | LNK | 1988-04-11 | 87 |
| K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | HHR | 1988-03-24 | 69 |
| K880170 | MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | LLO | 1988-03-24 | 69 |
| K880172 | MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. | LKW | 1988-03-11 | 56 |
44 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cooper Lasersonics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cooper Biomedical, Inc. (19 510(k)s)
- Cooper-Hewitt Electric Co. (8 510(k)s)
- Cooper Medical Devices Corp. (7 510(k)s)
- Cooper Surgical (6 510(k)s)
- Cooper Medical Corp. (5 510(k)s)
- Cooper Diagnostics, Inc. (1 510(k)s)
- Cooper Laboratories (1 510(k)s)
- Cooper Surgical/Aesthete (1 510(k)s)
- The Cooper Companies (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cooper Lasersonics, Inc.?
FDA lists 54 510(k) clearances under the applicant name “Cooper Lasersonics, Inc.” (first 1982, latest 1988), across 16 product codes in 8 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cooper Lasersonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cooper Lasersonics, Inc. is 77 days.
Which FDA product codes appear under Cooper Lasersonics, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 18); LNK (Laser For Gastro-Urology Use, 8); HHR (Laser, Surgical, Gynecologic, 4).
Next steps
- See all 54 Cooper Lasersonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Cooper Lasersonics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.