Yung Sheng Optical Co., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Yung Sheng Optical Co., Ltd.” (first 2013, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 102 days. Since 2017 the median was 328 days, against 111 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 |
|---|---|---|
| 2013 | 1 | 102 |
| 2014 | 2 | 78 |
| 2015 | 3 | 72 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 256 |
| 2023 | 1 | 384 |
| 2024 | 1 | 459 |
| 2025 | 1 | 273 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Yung Sheng Optical Co., Ltd. took a median 328 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 8 | 8 |
| MVN | Lens, Contact, (Disposable) | 2 | 2 |
Review panels
- Ophthalmic (10)
Most recent Yung Sheng Optical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) | LPL | 2025-09-25 | 273 |
| K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear | LPL | 2024-12-16 | 459 |
| K223585 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear | LPL | 2023-12-20 | 384 |
| K213983 | Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear | LPL | 2022-09-02 | 256 |
| K151586 | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens | LPL | 2015-08-10 | 60 |
| K150630 | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear | MVN | 2015-06-15 | 96 |
| K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens | MVN | 2015-01-16 | 72 |
| K143052 | Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens | LPL | 2014-12-16 | 54 |
| K133735 | EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | LPL | 2014-03-21 | 102 |
| K132854 | EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | LPL | 2013-12-23 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Yung Sheng Optical 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.
Device clinical trials
An industry sponsor named Yung Sheng Optical Co., Ltd. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06527586: A Study to Evaluate the Safety and Efficacy of Eye Secret UV Aspheric Silicone Soft (Hydrophilic) 1Day Color Contact Lens (Completed, started 2023-02-13)
- NCT06121531: A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Study of Silicone Hydrogel Monthly Soft Contact Lens for the Safety and Effectiveness in Visual Correction. (Completed, started 2021-02-01)
- NCT06128473: Clinical Evaluation of the Safety and Efficacy of Yung Sheng 38% Color Contact Lens (Completed, started 2013-06-18)
- NCT06128486: Clinical Evaluation of the Safety and Efficacy of Yung Sheng 55 % Color Contact Lens (Completed, started 2012-08-25)
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.
- Yung Chieh Ent. Co. , Ltd. (1 510(k)s)
- Yung Hsu Optical Works Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Yung Sheng Optical Co., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Yung Sheng Optical Co., Ltd.” (first 2013, latest 2025), 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 Yung Sheng Optical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Yung Sheng Optical Co., Ltd. is 102 days. Since 2017: 328 days, versus 111 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Yung Sheng Optical Co., Ltd.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 8); MVN (Lens, Contact, (Disposable), 2).
Next steps
- See all 10 Yung Sheng Optical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Yung Sheng Optical 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 (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.