Ion Laser Technology: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Ion Laser Technology” (first 1991, latest 1998), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 57 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 | 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 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ion Laser Technology?
FDA lists 9 510(k) clearances under the applicant name “Ion Laser Technology” (first 1991, latest 1998), across 2 product codes in 2 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 Ion Laser Technology?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ion Laser Technology is 57 days.
Which FDA product codes appear under Ion Laser Technology?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 6); EBZ (Activator, Ultraviolet, For Polymerization, 3).
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. 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.