Luvo Medical Technologies, Inc.: FDA clearances and approvals
Luvo Medical Technologies, Inc. has 5 FDA 510(k) clearances (first 2020, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time: 122 days. Since 2017 its median was 122 days, against 92 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 2 | 106 |
| 2021 | 3 | 182 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Luvo Medical Technologies, Inc.'s cleared 510(k)s took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 | 1 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 1 |
Review panels
Most recent Luvo Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212607 | Darwin | GEX | 2021-11-15 | 90 |
| K210129 | RF Thermal System | PBX | 2021-07-20 | 182 |
| K203728 | Darwin | GEX | 2021-07-14 | 205 |
| K193446 | Bare: 808 | GEX | 2020-03-10 | 89 |
| K193072 | Lucent : IPL | ONF | 2020-03-05 | 122 |
Recalls
openFDA lists no recalls under a recalling firm named Luvo Medical Technologies, 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 Luvo Medical Technologies, Inc. have?
Luvo Medical Technologies, Inc. has 5 FDA 510(k) clearances (first 2020, latest 2021), across 3 product codes in 1 review panel.
How long does FDA take to clear Luvo Medical Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Luvo Medical Technologies, Inc.'s cleared 510(k)s is 122 days. Since 2017: 122 days, versus 92 days for all cleared 510(k)s in the same product codes.
What devices does Luvo Medical Technologies, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 3); ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, 1); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 1).
Has Luvo Medical Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Luvo Medical Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 5 Luvo Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Luvo Medical Technologies, 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.