APL Medical System
by Bios S.R.L. 510(k)
Active
510(k) K072344
Overview
The APL Medical System is a modular, multi-laser and pulsed light device classified under product code GEX. It is designed to address common skin and body imperfections, including lesions, by delivering targeted energy through interchangeable handpieces. The system combines laser and light-based technologies to provide versatile treatment options for aesthetic and cosmetic applications. Its modular design allows for scalability and adaptability to various clinical needs.
The device is supplied as a portable, expandable platform containing core electronics and a cooling circuit, paired with removable handpieces for different treatment modalities. It is intended for single-use applications in controlled clinical settings, such as dermatology and plastic surgery offices. The system requires proper storage in a clean, dry environment to maintain functionality and sterility. FDA clearance under 510(k) number K072344 confirms its regulatory compliance for aesthetic and surgical use in the specified advisory committee categories.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072344 | Date3 Dec 2007 | 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- Withdrawn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 is the APL Medical System used for?
The APL Medical System is designed to address common skin and body imperfections, such as lesions. It uses targeted energy delivered through interchangeable handpieces to provide versatile treatment options for aesthetic and cosmetic applications in dermatology and plastic surgery. The modular design allows clinicians to adapt the system to various clinical needs, ensuring flexibility for different procedures.
How is the APL Medical System supplied and intended for use?
The APL Medical System is supplied as a portable, expandable platform that includes core electronics, a cooling circuit, and removable handpieces for different treatment modalities. It is intended for single-use applications in controlled clinical settings, such as dermatology and plastic surgery offices. The modular design ensures scalability and adaptability to meet specific procedural requirements.
What storage conditions are required for the APL Medical System?
To maintain functionality and sterility, the APL Medical System must be stored in a clean, dry environment. Proper storage conditions are essential for preserving the device’s performance and ensuring it remains ready for use in clinical settings.
Is the APL Medical System approved for specific regulatory use?
Yes, the APL Medical System holds FDA clearance under 510(k) number K072344, confirming its regulatory compliance for aesthetic and surgical use in the General and Plastic Surgery advisory committee categories. This clearance supports its intended use in dermatology and plastic surgery settings.
Can the APL Medical System be reused or is it single-use?
The APL Medical System is intended for single-use applications in controlled clinical settings. While the core electronics and cooling circuit are reusable components of the platform, the handpieces and associated consumables are designed for single-use to ensure patient safety and sterility.