Good Doctors Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Good Doctors Co., Ltd.” (first 2007, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 255 days. Since 2017 the median was 268 days, against 178 days for all cleared 510(k)s in the same product codes. 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 | 1 | 267 |
| 2017 | 0 | — |
| 2018 | 2 | 262 |
| 2019 | 0 | — |
| 2020 | 1 | 566 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 255 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Good Doctors Co., Ltd. took a median 268 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 178 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | 4 | 4 |
| LQY | Locator, Root Apex | 2 | 2 |
| NBL | Light-Induced Fluorescence Caries Detector | 1 | 1 |
Review panels
- Dental (7)
Most recent Good Doctors Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) | EBZ | 2023-08-04 | 255 |
| K183471 | IC-WHCD100 (Inspire) | NBL | 2020-07-02 | 566 |
| K173157 | Dr's Light2 | EBZ | 2018-05-29 | 242 |
| K171867 | Drs Finder NEO | LQY | 2018-03-30 | 281 |
| K151274 | Dr's Finder | LQY | 2016-02-04 | 267 |
| K093751 | CL-DC20, CL-DC21 | EBZ | 2010-02-24 | 79 |
| K071908 | DOCTOR'S LIGHT LED DENTAL CURING LIGHT | EBZ | 2007-08-23 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Good Doctors 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.
- Good Biotech Corp. (8 510(k)s)
- Good Clean Love, Inc. (8 510(k)s)
- Good Sleep CO Pte , Ltd. (3 510(k)s)
- Good Bond Industrial Corp. (2 510(k)s)
- Good Glove Corp. (2 510(k)s)
- Good Medy Enterprise , Ltd. (1 510(k)s)
- Good Methods Global, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Good Doctors Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Good Doctors Co., Ltd.” (first 2007, latest 2023), across 3 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 Good Doctors Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Good Doctors Co., Ltd. is 255 days. Since 2017: 268 days, versus 178 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Good Doctors Co., Ltd.?
The most frequent FDA product codes under this applicant name are EBZ (Activator, Ultraviolet, For Polymerization, 4); LQY (Locator, Root Apex, 2); NBL (Light-Induced Fluorescence Caries Detector, 1).
Next steps
- See all 7 Good Doctors Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBZ, Good Doctors 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.