Premier Laser Systems, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Premier Laser Systems, Inc.” (first 1994, latest 1999), across 1 product code in 1 review panel. Median 510(k) review time under this name: 149 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 | 14 | 14 |
Review panels
Most recent Premier Laser Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993285 | AURORA SL | GEX | 1999-11-18 | 49 |
| K992374 | AURORA HL | GEX | 1999-09-22 | 69 |
| K992620 | BLULAZE | GEX | 1999-08-20 | 15 |
| K981379 | AURORA | GEX | 1998-11-23 | 221 |
| K983211 | CENTAURI | GEX | 1998-10-09 | 25 |
| K980559 | PEGASUS ND:YAG LASER SYSTEM | GEX | 1998-08-24 | 192 |
| K974586 | AURORA DIODE LASER SYSTEM | GEX | 1998-07-15 | 218 |
| K980561 | DERMIUM | GEX | 1998-03-19 | 34 |
| K971118 | ARAGO | GEX | 1997-12-16 | 270 |
| K933841 | CENTAURI | GEX | 1997-05-05 | 1370 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Premier Laser Systems, 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.
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.
- Premier Dental Products Co. (41 510(k)s)
- Premier North America, Inc. (6 510(k)s)
- Premier Dental Company Products (3 510(k)s)
- Premier Dental Products Company (3 510(k)s)
- Premier Medical (3 510(k)s)
- Premier Biotech, Inc. (2 510(k)s)
- Premier (1 510(k)s)
- Premier Anesthesia Systems (1 510(k)s)
- Premier Brands of America, Inc. (1 510(k)s)
- Premier Dental (1 510(k)s)
- Premier Designs (1 510(k)s)
- Premier Dynamics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Premier Laser Systems, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Premier Laser Systems, Inc.” (first 1994, latest 1999), 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 Premier Laser Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Premier Laser Systems, Inc. is 149 days.
Which FDA product codes appear under Premier Laser Systems, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 14).
Next steps
- See all 14 Premier Laser Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Premier Laser Systems, 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.