Laserguide: FDA clearances and approvals
Laserguide has 5 FDA 510(k) clearances (first 1987, latest 1988), across 4 product codes in 3 review panels. Median 510(k) review time: 65 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 | 2 | 2 |
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | 1 | 1 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 1 | 1 |
| LNK | Laser For Gastro-Urology Use | 1 | 1 |
Review panels
Most recent Laserguide 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880071 | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE | FCS | 1988-03-22 | 71 |
| K875104 | SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE | LLO | 1988-02-02 | 46 |
| K873892 | SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE | LNK | 1988-02-02 | 132 |
| K873664 | LIGHT-SPOT FIBEROPTIC LASER HANDPIECE | GEX | 1987-11-06 | 57 |
| K873571 | LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE | GEX | 1987-11-06 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Laserguide.
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 Laserguide have?
Laserguide has 5 FDA 510(k) clearances (first 1987, latest 1988), across 4 product codes in 3 review panels.
How long does FDA take to clear Laserguide's 510(k)s?
The median time from FDA receipt to decision across Laserguide's cleared 510(k)s is 65 days.
What devices does Laserguide make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 2); FCS (Light, Catheter, Fiberoptic, Glass, Ureteral, 1); LLO (Laser, Neodymium:Yag, Pulmonary Surgery, 1).
Has Laserguide had device recalls?
openFDA lists no recalls under a recalling firm name matching Laserguide. Related entities may recall under other names.
Next steps
- See all 5 Laserguide clearances with predicates and recalls
- Run predicate analysis for product code GEX, Laserguide'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.