Lhasa Oms, Inc.: FDA clearances and approvals
Lhasa Oms, Inc. has 8 FDA 510(k) clearances (first 2005, latest 2021), across 3 product codes in 2 review panels. Median 510(k) review time: 252 days.
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 | 1 | 330 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Lhasa Oms, Inc.'s cleared 510(k)s took a median 330 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 6 | 6 |
| BWK | Stimulator, Electro-Acupuncture | 1 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
Review panels
- Neurology (7)
- Physical Medicine (1)
Most recent Lhasa Oms, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200636 | AXUS ES-5 Electro-Acupuncture Device | BWK | 2021-02-03 | 330 |
| K062003 | NEURO WAVE 6 | GZJ | 2007-09-19 | 429 |
| K060517 | POINTER EXCEL | GZJ | 2006-06-19 | 112 |
| K060508 | POINTER PLUS | GZJ | 2006-06-19 | 112 |
| K061080 | IR PRO 250 | ILY | 2006-06-14 | 57 |
| K050989 | AWQ-104 | GZJ | 2006-04-06 | 352 |
| K051020 | ES-160 | GZJ | 2006-02-24 | 308 |
| K050435 | E-STIM II | GZJ | 2005-09-06 | 196 |
Recalls
openFDA lists no recalls under a recalling firm named Lhasa Oms, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Lhasa Oms, Inc. have?
Lhasa Oms, Inc. has 8 FDA 510(k) clearances (first 2005, latest 2021), across 3 product codes in 2 review panels.
How long does FDA take to clear Lhasa Oms, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lhasa Oms, Inc.'s cleared 510(k)s is 252 days.
What devices does Lhasa Oms, Inc. make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 6); BWK (Stimulator, Electro-Acupuncture, 1); ILY (Lamp, Infrared, Therapeutic Heating, 1).
Has Lhasa Oms, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lhasa Oms, Inc. Related entities may recall under other names.
Next steps
- See all 8 Lhasa Oms, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Lhasa Oms, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.