Endo Lase, Inc.
United StatesFDA applicant, unverified
- Devices
- 24
What Endo Lase, Inc. makes
Endo Lase, Inc. manufactures CO₂ and Nd:YAG laser systems for surgical procedures in otorhinolaryngology, urology, bronchoscopy, and rectal pathology, including external genitalia treatments. Their portfolio includes flexible liquid light guides for laser delivery and infrared coagulators for tissue sealing. Devices are designed for endoscopic and direct surgical applications, such as treating obstructions, coagulating tissue, and addressing rectal and urological pathologies.
The company’s products are regulated under FDA Class II and Class III classifications, requiring 510(k) clearance or Premarket Approval (PMA) pathways. Devices are listed in the FDA’s 510(k) registry, reflecting their authorised status for commercial distribution in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 24 devicesFrequently asked questions
How many devices does Endo Lase, Inc. have in the registry?
The registry currently lists 24 devices for Endo Lase, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Endo Lase, Inc.'s devices?
Among its 24 most recently registered devices, Endo Lase, Inc. has devices listed in FDA 510(k) (24 devices).
What risk classes do Endo Lase, Inc.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Endo Lase, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Endo Lase, Inc. in the registry?
The most recently registered devices listed for Endo Lase, Inc. include ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY, FLEXIBLE LIQUID LIGHT GUIDE, UTILIZATION OF ND:YAG LASER FOR TREATMENT RECTAL P and INFRARED COAGULATOR.