Sunny Sunglasses: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sunny Sunglasses” (first 1994, latest 1994), across 1 product code in 1 review panel. Median 510(k) review time under this name: 148 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 6 | 6 |
Review panels
- Ophthalmic (6)
Most recent Sunny Sunglasses 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940924 | SUNGLASSES | HQY | 1994-07-12 | 134 |
| K940629 | YEOU NAN SUNGLASSES CO | HQY | 1994-07-12 | 148 |
| K940628 | JIHN MEI OPTICAL CO. | HQY | 1994-07-12 | 148 |
| K940627 | WENZHOU IMPORT AND EXPORT CORP | HQY | 1994-07-12 | 148 |
| K940626 | CLEVER OPTICAL INDUSTRIES LTD | HQY | 1994-07-12 | 148 |
| K940625 | CHEN SHUENG ENTERPRISE CO. | HQY | 1994-07-12 | 148 |
Recalls
openFDA lists no recalls under a recalling firm named Sunny Sunglasses.
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.
- Sunny Medical Device (Shenzhen) Co., Ltd. (6 510(k)s)
- Sunny Union Industrial Co., Ltd. (2 510(k)s)
- Sunny Optical Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sunny Sunglasses?
FDA lists 6 510(k) clearances under the applicant name “Sunny Sunglasses” (first 1994, latest 1994), 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 Sunny Sunglasses?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sunny Sunglasses is 148 days.
Which FDA product codes appear under Sunny Sunglasses?
The most frequent FDA product codes under this applicant name are HQY (Sunglasses (Non-Prescription Including Photosensitive), 6).
Next steps
- See all 6 Sunny Sunglasses clearances with predicates and recalls
- Run predicate analysis for product code HQY, Sunny Sunglasses'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.