Advanced Technology Laser Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Advanced Technology Laser Co., Ltd.” (first 2009, latest 2014), across 1 product code in 1 review panel. Median 510(k) review time under this name: 34 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 | 1 | 250 |
| 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 | 5 | 5 |
Review panels
Most recent Advanced Technology Laser Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140249 | LONG PULSE ND: YAG LASER SYSTEM | GEX | 2014-10-08 | 250 |
| K101555 | CO2 LASER SYSTEM | GEX | 2010-09-17 | 105 |
| K102050 | Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 | GEX | 2010-07-29 | 8 |
| K083918 | ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 | GEX | 2009-02-02 | 34 |
| K083915 | ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC | GEX | 2009-01-29 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Technology Laser Co., Ltd..
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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Technology Laser Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Advanced Technology Laser Co., Ltd.” (first 2009, latest 2014), 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 Advanced Technology Laser Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Technology Laser Co., Ltd. is 34 days.
Which FDA product codes appear under Advanced Technology Laser Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5).
Next steps
- See all 5 Advanced Technology Laser Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Advanced Technology Laser Co., Ltd.'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.