Laserscope: FDA clearances and approvals
Laserscope has 60 FDA 510(k) clearances (first 1985, latest 2006), across 8 product codes in 4 review panels. Median 510(k) review time: 90 days.
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 | 49 | 49 |
| LNK | Laser For Gastro-Urology Use | 3 | 3 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 2 | 2 |
| HHR | Laser, Surgical, Gynecologic | 2 | 2 |
| FBO | Cystourethroscope | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| LMS | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology | 1 | 1 |
Review panels
- General and Plastic Surgery (51)
- Gastroenterology and Urology (4)
- Ear, Nose and Throat (3)
- Obstetrics and Gynecology (2)
Most recent Laserscope 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062719 | GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES | GEX | 2006-12-01 | 80 |
| K061646 | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES | FBO | 2006-06-27 | 15 |
| K034011 | GEMINI SURGICAL LASER SYSTEM & ACCESSORIES | GEX | 2004-03-30 | 97 |
| K024206 | AURA ISURGICAL LASER SYSTEM & ACCESSORIES | GEX | 2003-11-17 | 332 |
| K020021 | LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) | GEX | 2002-07-02 | 180 |
| K010834 | LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES | GEX | 2001-05-21 | 62 |
| K010284 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | GEX | 2001-05-01 | 90 |
| K003765 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | GEX | 2001-03-06 | 90 |
| K003147 | LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) | GEX | 2000-12-15 | 66 |
| K990718 | ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | GEX | 2000-03-08 | 370 |
50 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Laserscope.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Laserscope have?
Laserscope has 60 FDA 510(k) clearances (first 1985, latest 2006), across 8 product codes in 4 review panels.
How long does FDA take to clear Laserscope's 510(k)s?
The median time from FDA receipt to decision across Laserscope's cleared 510(k)s is 90 days.
What devices does Laserscope make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 49); LNK (Laser For Gastro-Urology Use, 3); EWG (Laser, Ent Microsurgical Carbon-Dioxide, 2).
Has Laserscope had device recalls?
openFDA lists no recalls under a recalling firm name matching Laserscope. Related entities may recall under other names.
Next steps
- See all 60 Laserscope clearances with predicates and recalls
- Run predicate analysis for product code GEX, Laserscope's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.