Kam Yuen Plastic Products , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Kam Yuen Plastic Products , Ltd.” (first 2019, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 180 days. Since 2017 the median was 180 days, against 87 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 |
|---|---|---|
| 2019 | 1 | 184 |
| 2020 | 0 | — |
| 2021 | 1 | 80 |
| 2022 | 2 | 240 |
| 2023 | 1 | 82 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 175 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kam Yuen Plastic Products , Ltd. took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 87 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAP | Laser, Comb, Hair | 2 | 2 |
| OHT | Light Based Over-The-Counter Hair Removal | 2 | 2 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 1 | 1 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 | 1 |
Review panels
Most recent Kam Yuen Plastic Products , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | OHS | 2026-08-31 | 175 |
| K230107 | Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 | OHT | 2023-04-05 | 82 |
| K213027 | Laser Hair Growth Comb | OAP | 2022-05-26 | 247 |
| K213025 | Laser hair growth helmet | OAP | 2022-05-12 | 233 |
| K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | ONF | 2021-12-02 | 80 |
| K190820 | Aimanfun Lumea Comfort | OHT | 2019-10-02 | 184 |
Recalls
openFDA lists no recalls under a recalling firm named Kam Yuen Plastic Products , 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kam Yuen Plastic Products , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Kam Yuen Plastic Products , Ltd.” (first 2019, latest 2026), across 4 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 Kam Yuen Plastic Products , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kam Yuen Plastic Products , Ltd. is 180 days. Since 2017: 180 days, versus 87 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kam Yuen Plastic Products , Ltd.?
The most frequent FDA product codes under this applicant name are OAP (Laser, Comb, Hair, 2); OHT (Light Based Over-The-Counter Hair Removal, 2); OHS (Light Based Over The Counter Wrinkle Reduction, 1).
Next steps
- See all 6 Kam Yuen Plastic Products , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OAP, Kam Yuen Plastic Products , 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.