Directed Energy, Inc.: FDA clearances and approvals
Directed Energy, Inc. has 39 FDA 510(k) clearances (first 1984, latest 1991), across 6 product codes in 6 review panels. Median 510(k) review time: 90 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 24 | 24 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 5 | 5 |
| HHR | Laser, Surgical, Gynecologic | 4 | 4 |
| LNK | Laser For Gastro-Urology Use | 4 | 4 |
| HQF | Laser, Ophthalmic | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Review panels
- General and Plastic Surgery (24)
- Ear, Nose and Throat (5)
- Gastroenterology and Urology (4)
- Obstetrics and Gynecology (4)
- Ophthalmic (1)
- Orthopedic (1)
Most recent Directed Energy, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K904930 | SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH | GEX | 1991-03-21 | 141 |
| K894241 | MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT | GEX | 1990-06-18 | 362 |
| K883738 | CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. | GEX | 1988-11-15 | 75 |
| K882926 | MODEL AU-1 ACCESSORY UNIT | GEX | 1988-09-09 | 58 |
| K880216 | MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. | GEX | 1988-03-04 | 44 |
| K873331 | ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG | HRX | 1988-02-17 | 182 |
| K872709 | MODEL 20-C, RL-20A/U, OB-10A/U | HHR | 1988-02-02 | 210 |
| K870841 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN | HHR | 1988-02-02 | 341 |
| K872711 | MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY | GEX | 1987-09-28 | 83 |
| K872710 | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT | EWG | 1987-09-24 | 79 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Directed Energy, 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 Directed Energy, Inc. have?
Directed Energy, Inc. has 39 FDA 510(k) clearances (first 1984, latest 1991), across 6 product codes in 6 review panels.
How long does FDA take to clear Directed Energy, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Directed Energy, Inc.'s cleared 510(k)s is 90 days.
What devices does Directed Energy, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 24); EWG (Laser, Ent Microsurgical Carbon-Dioxide, 5); HHR (Laser, Surgical, Gynecologic, 4).
Has Directed Energy, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Directed Energy, Inc. Related entities may recall under other names.
Next steps
- See all 39 Directed Energy, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Directed Energy, 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.