Identifiers
- 510(k) Number
- K173038 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CuRAS Nd:YAG Laser is a Powered Laser Surgical Instrument (21 CFR 878.4810) designed for use in general and plastic surgery, as well as dermatology. It employs neodymium-doped yttrium aluminum garnet (Nd:YAG) technology to deliver precise laser energy for tissue ablation, coagulation, or vascular targeting in clinical procedures.
This device is supplied as a trolley-mounted system and is intended for single-use or reusable applications, depending on manufacturer specifications. It is regulated under FDA 510(k) clearance (K173038) as substantially equivalent (SESE) to predicate devices, with no explicit MRI safety classification noted. Storage and handling follow standard laser surgical instrument protocols, adhering to regulatory and clinical guidelines for laser-based procedures.
Frequently asked questions
What types of medical procedures is the CuRAS Nd:YAG Laser primarily used for, and why is Nd:YAG technology significant in these applications?
The CuRAS Nd:YAG Laser is designed for general surgery, plastic surgery, and dermatology procedures. Nd:YAG (neodymium-doped yttrium aluminum garnet) technology is significant because it delivers precise laser energy for tissue ablation, coagulation, or targeted vascular treatments. This makes it particularly useful for procedures requiring controlled depth penetration and minimal thermal damage to surrounding tissues, such as vascular lesion removal or skin resurfacing.
Is the CuRAS Nd:YAG Laser intended for single-use or reusable applications, and what considerations should be taken into account for its use?
The CuRAS Nd:YAG Laser is supplied as a system that can be used for either single-use or reusable applications, depending on the manufacturer’s specifications. For reusable applications, proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and performance. Single-use components should be handled according to manufacturer guidelines to avoid cross-contamination or damage. Always refer to the manufacturer’s instructions for specific use-case recommendations.
How is the CuRAS Nd:YAG Laser system physically supplied, and what storage requirements should be followed?
The CuRAS Nd:YAG Laser is supplied as a trolley-mounted system, meaning it is designed for easy mobility within clinical settings. Storage should follow standard protocols for laser surgical instruments, including protection from physical damage, extreme temperatures, and direct sunlight. Ensure the device is stored in a clean, dry environment and that any accessories or consumables are properly secured to maintain functionality and compliance with regulatory guidelines.
What regulatory pathway was followed for the FDA clearance of the CuRAS Nd:YAG Laser, and what does the product code GEX indicate?
The CuRAS Nd:YAG Laser received FDA clearance through a 510(k) submission (K173038) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) to predicate devices. The product code GEX categorizes this device under the FDA’s classification system for General and Plastic Surgery devices, specifically for powered laser surgical instruments (21 CFR 878.4810). This classification reflects its intended use in surgical and dermatological procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CuRAS Nd:YAG Laser (K173038) — FDA 510 (k) | Innolitics, Dermatology laser - CuRAS - Creative Ilooda - Nd:YAG / trolley-mounted, CuRAS Nd:YAG Laser 510 (k) K173038 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173038 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ilooda.co., Ltd
- FDA Applicant
- Ilooda Co,., Ltd.
Sources (1)
- FDA 510(k) K173038 24 fields · synced Sep 19, 2026