BIOSYAG 50 MED
by Bios S.R.L. 510(k)
Active
510(k) K043521
Overview
The BIOSYAG 50 MED is a medical laser system intended for the treatment of benign vascular lesions and for hair removal. It operates by delivering controlled laser energy to targeted tissue to achieve selective photothermolysis. The device is designed for use in clinical settings by qualified medical professionals.
The device is supplied as a single-unit system with associated delivery components and is intended for single-patient or multi-patient use following appropriate cleaning and sterilization protocols. It is stored in a dry, temperature-controlled environment and requires connection to standard electrical and cooling systems. The device has been reviewed under FDA 510(k) premarket notification with a substantial equivalence determination.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043521 | Date24 Mar 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bios S.R.L.
Questions
What clinical indications is the BIOSYAG 50 MED intended for?
The device is intended for the treatment of benign vascular lesions and for hair removal. It works by delivering controlled laser energy to targeted tissue to achieve selective photothermolysis, a process that selectively damages the target while sparing surrounding tissue.
Is the BIOSYAG 50 MED designed for single-patient or multi-patient use?
The device is supplied as a single-unit system with associated delivery components and is intended for both single-patient and multi-patient use, provided that appropriate cleaning and sterilization protocols are followed between patients to ensure safety and infection control.
What are the storage and operational requirements for the BIOSYAG 50 MED?
The device must be stored in a dry, temperature-controlled environment. Operation requires connection to standard electrical and cooling systems to maintain proper function and prevent overheating during clinical procedures.
Who is authorized to operate the BIOSYAG 50 MED?
The device is designed for use in clinical settings by qualified medical professionals. Proper training and adherence to clinical protocols are essential to ensure safe and effective operation.