Sharplan Lasers, Inc.: FDA filings under this applicant name
FDA lists 78 510(k) clearances under the applicant name “Sharplan Lasers, Inc.” (first 1986, latest 1997), across 8 product codes in 4 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 | 66 | 66 |
| LNK | Laser For Gastro-Urology Use | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| LFL | Instrument, Ultrasonic Surgical | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| MGI | Aspirator, Ultrasonic | 1 | 1 |
Review panels
- General and Plastic Surgery (70)
- Gastroenterology and Urology (4)
- Obstetrics and Gynecology (3)
- Radiology (1)
Most recent Sharplan Lasers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973354 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) | GEX | 1997-12-04 | 90 |
| K972099 | SHARPLAN EPITOUCH RUBY LASER SYSTEM | GEX | 1997-08-27 | 84 |
| K971874 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) | GEX | 1997-08-18 | 90 |
| K971648 | SHARPLAN ERBIUM: YAG LASER (4020) | GEX | 1997-07-23 | 79 |
| K971743 | SHARPLAN CO2 SURGICAL LASER SYSTEM | GEX | 1997-07-18 | 67 |
| K962446 | SHARPLAN RUBY LASER SYSTEM | GEX | 1997-03-07 | 256 |
| K963229 | SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS | GEX | 1996-11-05 | 78 |
| K961935 | SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER | GEX | 1996-11-01 | 165 |
| K962974 | SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) | GEX | 1996-08-21 | 21 |
| K961279 | SHARPLAN LASERS, INC. RUBY LASER SYSTEM | GEX | 1996-06-18 | 76 |
68 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sharplan Lasers, 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.
- Sharplan Industries, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sharplan Lasers, Inc.?
FDA lists 78 510(k) clearances under the applicant name “Sharplan Lasers, Inc.” (first 1986, latest 1997), across 8 product codes in 4 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 Sharplan Lasers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sharplan Lasers, Inc. is 77 days.
Which FDA product codes appear under Sharplan Lasers, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 66); LNK (Laser For Gastro-Urology Use, 4); GCJ (Laparoscope, General & Plastic Surgery, 2).
Next steps
- See all 78 Sharplan Lasers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Sharplan Lasers, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.