Directed Energy, Inc.
United StatesFDA applicant, unverified
- Devices
- 39
What Directed Energy, Inc. makes
Directed Energy, Inc. manufactures carbon dioxide (CO₂) laser systems designed for surgical applications, including general surgery, plastic surgery, ophthalmology, dermatology, and specialized procedures in obstetrics-gynecology (OB-GYN) and ear-nose-throat (ENT). Their portfolio includes both fixed and hand-held laser models, each paired with attachments tailored for specific medical uses, such as tissue ablation, skin resurfacing, and precision cutting.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance process. These products are intended for use in the United States, where they are subject to compliance with the Federal Food, Drug, and Cosmetic Act.
Catalogue
Search and filter all 39 devicesFrequently asked questions
How many devices does Directed Energy, Inc. have in the registry?
The registry currently lists 39 devices for Directed Energy, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Directed Energy, Inc.'s devices?
Among its 39 most recently registered devices, Directed Energy, Inc. has devices listed in FDA 510(k) (39 devices).
What risk classes do Directed Energy, Inc.'s devices fall under?
Among its 39 most recently registered devices, the classes recorded for Directed Energy, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Directed Energy, Inc. in the registry?
The most recently registered devices listed for Directed Energy, Inc. include CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH., MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE, MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY and MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT).