Biolitec, Inc.
United StatesFDA applicant, unverified
- Devices
- 29
What Biolitec, Inc. makes
Biolitec, Inc. manufactures diode laser systems and fiber optic delivery devices for medical applications, including the CERALAS D 980 and 810 diode laser systems (models D15, D25, D50, D100, and 150W), multiwavelength fiber-coupled lasers (980/1470nm), and non-sterile fiber optic and collimating handpiece systems (e.g., MEGABEAM models 200, 320, 400, 600µm, and SIDEFIBER). These devices are designed for procedures requiring precise laser energy delivery, such as dermatology, dentistry, and surgical applications.
The company’s portfolio includes devices classified as Class II and Class III under FDA regulations, with submissions recorded in the FDA’s 510(k) and PMA registries. These products are listed in the U.S. and governed by FDA clearance or approval pathways. Biolitec, Inc. is headquartered in the United States.
Catalogue
Search and filter all 29 devicesFrequently asked questions
How many devices does Biolitec, Inc. have in the registry?
The registry currently lists 29 devices for Biolitec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biolitec, Inc.'s devices?
Among its 29 most recently registered devices, Biolitec, Inc. has devices listed in FDA 510(k) (28 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Biolitec, Inc.'s devices fall under?
Among its 29 most recently registered devices, the classes recorded for Biolitec, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Biolitec, Inc. in the registry?
The most recently registered devices listed for Biolitec, Inc. include CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50, CERALAS D 810 DIODE LASER SYSTEM, MODEL D15, MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200, 320, 400 OR 600UM and 100W CERALAS D 980 LASER SYSTEM, MODEL D100.