Lightfusion LED System
510(k) K162556
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162556 | Date24 Mar 2017 | 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- Withdrawn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, 20 Sep 2026
The Lightfusion LED System is a powered laser surgical instrument classified under Powered Laser Surgical Instrument (Product Code GEX) and designed for photobiomodulation. It emits non-thermal red (630 nm) and near-infrared (830 nm) light via LED face pads, targeting periorbital wrinkles through controlled energy delivery in the red and near-infrared spectrum regions. This device operates as a portable, table-top unit, leveraging LED technology to provide localized treatment without thermal effects.
The Lightfusion LED System is supplied as a reusable medical device and is intended for use in clinical settings by trained professionals. It is not sterile at shipment and requires appropriate cleaning and maintenance per manufacturer guidelines. The device holds FDA 510(k) clearance (K162556) under the Substantially Equivalent (SESE) determination, classified for general and plastic surgery applications. Compliance with regulatory standards ensures safe integration into surgical or aesthetic treatment workflows.
Questions
AI-generated answers, 20 Sep 2026
What specific types of skin concerns does the Lightfusion LED System target, and how does it work?
The Lightfusion LED System targets periorbital wrinkles by delivering photobiomodulation through non-thermal red (630 nm) and near-infrared (830 nm) LED light. Unlike thermal treatments, it avoids heat-related damage while promoting localized tissue response to reduce fine lines around the eyes.
Is the Lightfusion LED System intended for use in surgical or aesthetic procedures, and who should operate it?
The device is classified under Powered Laser Surgical Instruments (Product Code GEX) and is designed for use in clinical settings by trained professionals, though it’s not explicitly limited to surgical contexts. Its FDA clearance under General/Plastic Surgery (SU Advisory Committee) suggests suitability for aesthetic treatments like wrinkle reduction, but operation requires proper training.
How is the Lightfusion LED System supplied, and what cleaning or maintenance is required?
The Lightfusion LED System is a reusable medical device shipped non-sterile, so it must be cleaned and maintained according to the manufacturer’s guidelines before each use. Unlike single-use devices, it’s built for repeated clinical applications but requires proper sterilization procedures between patients.
What regulatory pathway did the Lightfusion LED System follow to gain FDA clearance, and what does that mean for its use?
The device received FDA 510(k) clearance (K162556) under a Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed predicate device. This clearance allows its use in clinical settings for photobiomodulation, but clinicians should confirm compliance with current FDA guidelines and manufacturer instructions for safe integration into their workflow.