A.R.C. Laser Corp.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “A.R.C. Laser Corp.” (first 2000, latest 2000), across 1 product code in 1 review panel. Median 510(k) review time under this name: 282 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 | 1 | 1 |
Review panels
Most recent A.R.C. Laser Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993154 | LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM | GEX | 2000-06-29 | 282 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-06-06.
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 A.R.C. Laser Corp.?
FDA lists 1 510(k) clearance under the applicant name “A.R.C. Laser Corp.” (first 2000, latest 2000), 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 A.R.C. Laser Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name A.R.C. Laser Corp. is 282 days.
Which FDA product codes appear under A.R.C. Laser Corp.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 1 A.R.C. Laser Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEX, A.R.C. Laser 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.