Biolitec Medical Devices, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Biolitec Medical Devices, Inc. makes
Biolitec Medical Devices, Inc. manufactures fiber optic laser delivery systems and laser devices for medical procedures, including radial-emitting, reusable, and side-fire optical fibers, as well as handpieces and tips for targeted tissue treatment. Their portfolio includes endovascular laser vein systems, endoculary probes, and diode lasers operating at 980nm and 1470nm wavelengths for specialized medical applications.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) registry, reflecting compliance with U.S. medical device authorization requirements. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Megabeam Reusable Fiber Optic Delivery System Ref K113688
Regimes: 510(k) Registry: 510(k)Twister Side Fire Optical Fiber Delivery System Ref K112987
Regimes: 510(k) Registry: 510(k)Megabeam Endo-Ent Probe Ref K113858
Regimes: 510(k) Registry: 510(k)Endovascular Laser Vein System Kit Ref K112299
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Ceralas 980NM Diode Laser Family Ref K112324
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biolitec Medical Devices, Inc. have in the registry?
The registry currently lists 9 devices for Biolitec Medical Devices, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biolitec Medical Devices, Inc.'s devices?
Among its 9 most recently registered devices, Biolitec Medical Devices, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Biolitec Medical Devices, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Biolitec Medical Devices, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biolitec Medical Devices, Inc. in the registry?
The most recently registered devices listed for Biolitec Medical Devices, Inc. include RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM, MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE, MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM and TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM.