Nlite System
510(k) K014130
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK014130 | Date8 Jan 2002 | 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- Withdrawn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
- FDA applicant
- Icn Photonics , Ltd.
- 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 NLite System Model A00-1051 is a laser surgical instrument classified under FDA Product Code GEX, designed for use in general and plastic surgery as well as dermatology. It is intended for vascular lesion treatments, including port wine stains, telangiectasia, hemangiomas, and angiomas, leveraging laser technology for targeted tissue interaction.
This device is supplied by ICN Photonics Ltd. and is regulated under FDA 510(k) clearance (K020729) as a Class II medical device. It is intended for single-use or reusable applications in controlled clinical settings, adhering to sterility and safety standards for laser surgical instruments. No additional regulatory status beyond the stated FDA clearance is implied.
Other devices from Icn Photonics, Ltd.
Questions
AI-generated answers, 19 Sep 2026
What types of vascular lesions can the NLite System treat, and how does it work for these conditions?
The NLite System Model A00-1051 is specifically designed to treat vascular lesions such as port wine stains, telangiectasia (spider veins), hemangiomas (benign vascular tumors), and angiomas. It uses laser technology to target and interact with the blood vessels in these lesions, promoting selective absorption and tissue remodeling to improve appearance and reduce symptoms. The device’s classification under FDA Product Code GEX confirms its intended use in dermatology and vascular treatments.
Is the NLite System meant for single-use or can it be reused in a clinical setting?
The NLite System is intended for both single-use and reusable applications in controlled clinical settings, depending on facility protocols and sterilization practices. Since it is classified as a Class II laser surgical instrument under FDA 510(k) clearance, proper sterilization and maintenance procedures must be followed if reuse is chosen to ensure safety and efficacy. The manufacturer, ICN Photonics Ltd., provides guidance on sterility and reuse standards.
How is the NLite System supplied, and what should clinicians consider when storing it?
The NLite System is supplied by ICN Photonics Ltd. as a complete laser surgical instrument kit, though exact packaging details (e.g., sterile packaging, accessories) are not specified in the data. Clinicians should store the device in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality. If reusable, follow manufacturer-recommended sterilization protocols before use. Since it is a laser device, proper handling and maintenance of optical components are critical.
What regulatory pathway does the NLite System follow, and how does that affect its use in the U.S.?
The NLite System received FDA 510(k) clearance (K020729) as a Class II medical device, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with U.S. safety and performance standards for laser surgical instruments used in general/plastic surgery and dermatology. Clinicians can use it with confidence that it meets FDA requirements for its intended applications, though adherence to manufacturer instructions and facility protocols remains essential.