Lasersight Technologies, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Lasersight Technologies, Inc.” (first 1998, latest 2000), plus 2 PMA decisions, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 79 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | 3 | 3 |
| LZS | Excimer Laser System | 2 | 0 |
Review panels
- Ophthalmic (5)
Most recent Lasersight Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001144 | ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS | HNO | 2000-05-05 | 25 |
| K990227 | ULTRASHAPER KERATOME | HNO | 2000-01-31 | 371 |
| K974004 | AUTOMATED DISPOSABLE KERATOME (ADK) | HNO | 1998-01-08 | 79 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P980008 | PMA | LASERSCAN LSX EXCIMER LASER SYSTEM | 1999-11-12 |
| P970005 | PMA | KREMER LASER SYSTEM | 1998-07-30 |
Recalls
openFDA lists no recalls under a recalling firm named Lasersight Technologies, Inc..
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 Lasersight Technologies, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Lasersight Technologies, Inc.” (first 1998, latest 2000), plus 2 PMA decisions, across 2 product codes 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 Lasersight Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lasersight Technologies, Inc. is 79 days.
Which FDA product codes appear under Lasersight Technologies, Inc.?
The most frequent FDA product codes under this applicant name are HNO (Keratome, Ac-Powered, 3); LZS (Excimer Laser System, 2).
Next steps
- See all 3 Lasersight Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HNO, Lasersight Technologies, Inc.'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.