Bio Quantum Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Bio Quantum Technologies, Inc. makes
Bio Quantum Technologies, Inc. manufactures hand-held and microsurgical CO₂ laser systems designed for dermatological, ophthalmological, and surgical applications. Their devices include portable CO₂ lasers for dermatology (e.g., skin resurfacing) and precision microsurgical lasers for ophthalmic and soft-tissue procedures. Models like the HH-550 series and the 4100 system are tailored for controlled tissue ablation and coagulation in clinical settings.
The company’s CO₂ laser portfolio is classified under Class II medical devices in the U.S. and is listed via FDA 510(k) clearance. These devices are regulated under the U.S. Food and Drug Administration’s medical device authority, ensuring compliance with safety and performance standards for laser-based surgical instruments. The company operates from the United States.
Catalogue
Advanced Hand Held CO2 Laser/Hh-550 For Dggd Use Ref K864948
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Microsurgical CO2 Laser Sys - 4100 Ref K840406
Regimes: 510(k) Registry: 510(k)Advanced Hand Held CO2 Laser/Hh-550 For Doed Use Ref K864946
Regimes: 510(k) Registry: 510(k)Model 4100 Microsurgical CO2 Laser System Ref K837110
Regimes: 510(k) Registry: 510(k)Advanced Hand Held CO2 Laser Model Hh-550 For Su Ref K864887
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio Quantum Technologies, Inc. have in the registry?
The registry currently lists 6 devices for Bio Quantum Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio Quantum Technologies, Inc.'s devices?
Among its 6 most recently registered devices, Bio Quantum Technologies, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Bio Quantum Technologies, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Bio Quantum Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio Quantum Technologies, Inc. in the registry?
The most recently registered devices listed for Bio Quantum Technologies, Inc. include ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE, BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S, MICROSURGICAL CO2 LASER SYS - 4100 and ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE.