Dynatronics Laser Corp.: FDA clearances and approvals
Dynatronics Laser Corp. has 5 FDA 510(k) clearances (first 1987, latest 1993), across 5 product codes in 3 review panels. Median 510(k) review time: 156 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 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| HCC | Device, Biofeedback | 1 | 1 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| LBB | Dynamometer, Ac-Powered | 1 | 1 |
Review panels
- Neurology (3)
- Cardiovascular (1)
- Physical Medicine (1)
Most recent Dynatronics Laser Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920939 | DYNATRON 300 ULRASOUND | IMG | 1993-03-04 | 371 |
| K900639 | DYNATRON 350 EMG/BIOFEEDBACK ANALYZER | HCC | 1990-10-04 | 237 |
| K900321 | DYNATRON 330 BODY COMPOSITION ANALYZER | DSB | 1990-06-11 | 139 |
| K880464 | DYNATRON II | LBB | 1988-03-08 | 34 |
| K864370 | DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR) | GZJ | 1987-04-10 | 156 |
Recalls
openFDA lists no recalls under a recalling firm named Dynatronics Laser Corp..
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 Dynatronics Laser Corp. have?
Dynatronics Laser Corp. has 5 FDA 510(k) clearances (first 1987, latest 1993), across 5 product codes in 3 review panels.
How long does FDA take to clear Dynatronics Laser Corp.'s 510(k)s?
The median time from FDA receipt to decision across Dynatronics Laser Corp.'s cleared 510(k)s is 156 days.
What devices does Dynatronics Laser Corp. make?
Its most frequent FDA product codes are DSB (Plethysmograph, Impedance, 1); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1); HCC (Device, Biofeedback, 1).
Has Dynatronics Laser Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dynatronics Laser Corp. Related entities may recall under other names.
Next steps
- See all 5 Dynatronics Laser Corp. clearances with predicates and recalls
- Run predicate analysis for product code DSB, Dynatronics Laser Corp.'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.