Ion Laser Technology: FDA clearances and approvals
Ion Laser Technology has 9 FDA 510(k) clearances (first 1991, latest 1998), across 2 product codes in 2 review panels. Median 510(k) review time: 57 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 | 6 | 6 |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 | 3 |
Review panels
Most recent Ion Laser Technology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974369 | APOLLO 9500 | EBZ | 1998-01-06 | 47 |
| K964524 | ILT ARGON HP | EBZ | 1997-03-18 | 126 |
| K953898 | ACL-5500 PRECISION CURING UNIT (PCU) | EBZ | 1996-02-15 | 181 |
| K954460 | ILT SURGICAL LASER | GEX | 1995-12-18 | 84 |
| K950351 | CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) | GEX | 1995-03-24 | 53 |
| K944317 | GENESIS 2000 | GEX | 1994-10-11 | 43 |
| K944206 | GENESIS 2000 | GEX | 1994-10-11 | 43 |
| K915656 | CARBON DIOXIDE CO2 LASER | GEX | 1992-04-10 | 114 |
| K914726 | ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED | GEX | 1991-12-17 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Ion Laser Technology.
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 Ion Laser Technology have?
Ion Laser Technology has 9 FDA 510(k) clearances (first 1991, latest 1998), across 2 product codes in 2 review panels.
How long does FDA take to clear Ion Laser Technology's 510(k)s?
The median time from FDA receipt to decision across Ion Laser Technology's cleared 510(k)s is 57 days.
What devices does Ion Laser Technology make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 6); EBZ (Activator, Ultraviolet, For Polymerization, 3).
Has Ion Laser Technology had device recalls?
openFDA lists no recalls under a recalling firm name matching Ion Laser Technology. Related entities may recall under other names.
Next steps
- See all 9 Ion Laser Technology clearances with predicates and recalls
- Run predicate analysis for product code GEX, Ion Laser Technology'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.