Ya-Man, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ya-Man, Ltd.” (first 2001, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 200 days. Since 2017 the median was 243 days, against 94 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 | 1 | 211 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 520 |
| 2024 | 0 | — |
| 2025 | 2 | 130 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ya-Man, Ltd. took a median 243 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
Review panels
Most recent Ya-Man, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250618 | Medi Lift Essential Eye Mask | NFO | 2025-10-29 | 243 |
| K244048 | Medi Lift Mask | NFO | 2025-01-16 | 16 |
| K220198 | Medi Lift PLUS | NFO | 2023-06-28 | 520 |
| K112016 | L-SER KO LAMP | ILY | 2012-02-10 | 211 |
| K032944 | YA-MAN LASER 21 | GEX | 2003-12-19 | 88 |
| K011021 | LASER 20 | GEX | 2001-10-09 | 188 |
Recalls
openFDA lists no recalls under a recalling firm named Ya-Man, 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 Ya-Man, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Ya-Man, Ltd.” (first 2001, latest 2025), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ya-Man, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ya-Man, Ltd. is 200 days. Since 2017: 243 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ya-Man, Ltd.?
The most frequent FDA product codes under this applicant name are NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 3); GEX (Powered Laser Surgical Instrument, 2); ILY (Lamp, Infrared, Therapeutic Heating, 1).
Next steps
- See all 6 Ya-Man, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NFO, Ya-Man, 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.