Laser Spectrum, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Laser Spectrum, Inc. makes
Laser Spectrum, Inc. manufactures carbon dioxide (CO₂) laser systems and accessories for surgical and diagnostic procedures, including laparoscopic puncture lasers, portable laser devices, and bronchoscopy laser attachments. Their products also include CO₂ laser micromanipulators and compatible laparoscopes designed for precision tissue treatment.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory clearance obtained through the 510(k) pathway. These products are listed in the FDA’s 510(k) database and are based in the United States.
Catalogue
Daniell Dbl Puncture Laser Laparoscopy Ref K842498
Regimes: 510(k) Registry: 510(k)Model 305AA Portable Laser Ref K841781
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
CO2 Laparoscope Ref K841668
Regimes: 510(k) Registry: 510(k)CO2 Laser Micromanipulator Ref K863520
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Laser Spectrum, Inc. have in the registry?
The registry currently lists 5 devices for Laser Spectrum, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Laser Spectrum, Inc.'s devices?
Among its 5 most recently registered devices, Laser Spectrum, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Laser Spectrum, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Laser Spectrum, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Laser Spectrum, Inc. in the registry?
The most recently registered devices listed for Laser Spectrum, Inc. include DANIELL DBL PUNCTURE LASER LAPAROSCOPY, MODEL 305AA PORTABLE LASER, ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN and CO2 LAPAROSCOPE.