Scantech Laser Scanner
510(k) K974633
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974633 | Date16 Jan 1998 | 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- Withdrawn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, 19 Sep 2026
The Scantech Laser Scanner is a handheld 3D laser scanning device classified under the General & Plastic Surgery category (Product Code: GEX). It functions as a laser-based imaging tool designed to capture precise three-dimensional surface data, enabling applications in metrology, reverse engineering, and medical laser-assisted procedures.
This device is supplied as a reusable handpiece integrated with Phantom Family Medical Lasers, featuring dual galvo X-Y scanning technology. Cleared under FDA 510(k) (K974633) via the Traditional pathway, it is intended for use in surgical settings where laser energy delivery is required. No specific sterility or MRI safety information is provided in the data.
Other devices from Phantom Technologies, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of medical procedures is the Scantech Laser Scanner designed to assist with, and how does it integrate with other equipment?
The Scantech Laser Scanner is designed to assist in surgical settings where laser energy delivery is required, particularly within general and plastic surgery applications. It functions as a handheld 3D laser scanning tool that captures precise surface data, enabling applications like metrology and reverse engineering. It is integrated as a reusable handpiece with Phantom Family Medical Lasers, utilizing dual galvo X-Y scanning technology to enhance laser precision during procedures.
Is the Scantech Laser Scanner intended for single-use or reusable applications, and what does this mean for maintenance and cleaning?
The Scantech Laser Scanner is explicitly designed as a reusable handpiece, meaning it is meant to be used repeatedly across multiple procedures. Since it is not single-use, proper maintenance and cleaning protocols will be necessary to ensure its functionality and sterility between uses, particularly in surgical settings where hygiene is critical.
What are the key features of the Scantech Laser Scanner’s scanning technology, and how might they benefit a clinician?
The Scantech Laser Scanner utilizes dual galvo X-Y scanning technology, which allows it to capture highly precise three-dimensional surface data. This feature is particularly beneficial for clinicians performing laser-assisted procedures, as it enables accurate imaging and alignment, improving the precision and outcomes of surgical interventions in fields like general and plastic surgery.
How was the FDA clearance for the Scantech Laser Scanner determined, and what does this mean for its regulatory status?
The Scantech Laser Scanner was cleared under the FDA’s 510(k) pathway (K974633) via the Traditional route, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined that the device is as safe and effective as a legally marketed predecessor, confirming its regulatory compliance for use in surgical settings as described. The clearance falls under the General & Plastic Surgery category (Product Code: GEX).