Intra Lase Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Intra Lase Corp.” (first 1999, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 143 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 | 9 | 9 |
Review panels
Most recent Intra Lase Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073404 | IFS LASER SYSTEM | GEX | 2008-04-25 | 143 |
| K063682 | INTRALASE FUSION LASER | GEX | 2007-02-09 | 60 |
| K060372 | INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3 | GEX | 2006-08-16 | 184 |
| K041893 | INTRALASE FS LASER | GEX | 2005-07-29 | 381 |
| K031960 | INTRALASE FS LASER | GEX | 2003-09-29 | 96 |
| K013941 | PULSION FS LASER KERATOME | GEX | 2002-02-27 | 90 |
| K002890 | INTRALASE 600C LASER KERATOME | GEX | 2001-08-09 | 328 |
| K001211 | MODIFICATION TO INTRALASE 600C LASER KERATOME | GEX | 2000-12-04 | 234 |
| K993153 | INTRALASE 600C LASER KERATOME | GEX | 1999-12-17 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Intra Lase Corp..
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.
- Intra Luminal Therapeutics, Inc. (20 510(k)s)
- Intra-Lock International (13 510(k)s)
- Intra-Optics Labs. C/O Newman Assoc. (1 510(k)s)
- Intra-Sonix, Inc. (1 510(k)s)
- Intra Special Catheters GmbH (1 510(k)s)
- Intra Vantage, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intra Lase Corp.?
FDA lists 9 510(k) clearances under the applicant name “Intra Lase Corp.” (first 1999, latest 2008), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intra Lase Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intra Lase Corp. is 143 days.
Which FDA product codes appear under Intra Lase Corp.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 9).
Next steps
- See all 9 Intra Lase Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Intra Lase Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.