Apex Er:Yag / IPL System
by Sandstone Medical Technologies, LLC
510(k) K110304
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110304 | Date8 Apr 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 27 Sep 2026
The Apex Er:Yag / IPL System is a medical device that combines both Erbium:YAG (Er:YAG) and Intense Pulsed Light (IPL) technologies for treatment purposes. This system is designed for use in various medical applications, including those in general and plastic surgery.
The device is supplied by Sandstone Medical Technologies, LLC and has received FDA 510(k) clearance with the number K110304. It is regulated under product code GEX and is intended for use in clinical settings. The system is available in various configurations as specified by the manufacturer.
Other devices from Sandstone Medical Technologies, LLC
Questions
AI-generated answers, 27 Sep 2026
What is the APEX ER.YAG/IPL System used for?
The APEX ER.YAG/IPL System is a medical device that combines Erbium:YAG and Intense Pulsed Light technologies for various medical applications, particularly in general and plastic surgery settings.
How is the APEX ER.YAG/IPL System supplied?
The system is supplied by Sandstone Medical Technologies, LLC in various configurations as specified by the manufacturer, designed for use in clinical environments.
What regulatory status does the APEX ER.YAG/IPL System have?
The device has received FDA 510(k) clearance with number K110304 and is regulated under product code GEX, classified for use in general and plastic surgery applications.
Is the APEX ER.YAG/IPL System reusable or single-use?
The device information does not specify whether the system is reusable or single-use, as this would depend on the specific configuration and components selected by the user.