Surgilase, Inc.
United StatesFDA applicant, unverified
- Devices
- 19
What Surgilase, Inc. makes
Surgilase, Inc. manufactures surgical laser systems, including CO₂ laser waveguides and systems like the SL80, SL60, and SL45 models for general surgical applications. Their portfolio also covers Nd:YAG laser systems, such as the YAG 100 for neuro, pulmonary, orthopedic, and gynecological procedures, as well as standalone laser units rated at 25, 40, 45, 55, 60, 80, and 100 watts. Specialized variants include the SL50/60 Gold series for precision surgery.
The company’s devices are classified under FDA regulations as Class II and Class III, with submissions recorded in the FDA’s 510(k) clearance registry. These products are intended for use in the United States, where regulatory compliance is required for surgical lasers.
Catalogue
Search and filter all 19 devicesFrequently asked questions
How many devices does Surgilase, Inc. have in the registry?
The registry currently lists 19 devices for Surgilase, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgilase, Inc.'s devices?
Among its 19 most recently registered devices, Surgilase, Inc. has devices listed in FDA 510(k) (19 devices).
What risk classes do Surgilase, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Surgilase, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Surgilase, Inc. in the registry?
The most recently registered devices listed for Surgilase, Inc. include SURGILASE FIBERLASE CO2 LASER WAVEGUIDE, SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80, MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS and SURGILASE YAG 100 SURGICAL LASER SYSTEM.