CuRAS Nd:YAG Laser
510(k) K173038
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173038 | Date1 Dec 2017 | StatusActive |
Official records
- FDA 510(k) database K173038
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Ilooda Co,., 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 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.
Devices cleared under K173038
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CuRAS Articulated Arm QND Articulated Arm | QND Articulated Arm | 08800023200676 | On the market | |
| CuRAS Articulated Arm QND-C1 | QND-C1 | 08800016903829 | On the market | |
| CuRAS Collimation H/P QND Collimation H/P | QND Collimation H/P | 08800023200683 | On the market | |
| CuRAS Collimation Handpiece QND-C1 | QND-C1 | 08800016903836 | On the market | |
| CuRAS Collimation MLA Handpiece QND-C1 | QND-C1 | 08800016903874 | On the market | |
| CuRAS Fractional H/P QND Fractional H/P | QND Fractional H/P | 08800023200690 | On the market | |
| CuRAS Fractional Handpiece QND-C1 | QND-C1 | 08800016903850 | On the market | |
| CuRAS Main Head QND Main Head | QND Main Head | 08800023200713 | On the market | |
| CuRAS Main Unit QND Main Unit | QND Main Unit | 08800023200669 | On the market | |
| CuRAS Main Unit QND-C1 | QND-C1 | 08800016903812 | On the market | |
| CuRAS Set Package QND-C1 | QND-C1 | 08800016903805 | On the market | |
| CuRAS Zoom H/P QND Zoom H/P | QND Zoom H/P | 08800023200706 | On the market | |
| CuRAS Zoom Handpiece QND-C1 | QND-C1 | 08800016903843 | On the market | |
| CuRAS Zoom MLA Handpiece QND-C1 | QND-C1 | 08800016903867 | On the market | |
| QuRAS Articualed Arm QND Articualed Arm | QND Articualed Arm | 08800023200256 | On the market | |
| QuRAS Collimation H/P QND Collimation H/P | QND Collimation H/P | 08800023200270 | On the market | |
| QuRAS Fractional H/P QND Fractional H/P | QND Fractional H/P | 08800023200287 | On the market | |
| QuRAS Main Head QND Main Head | QND Main Head | 08800023200294 | On the market | |
| QuRAS Main Unit QND Main Unit | QND Main Unit | 08800023200249 | On the market | |
| QuRAS Zoom H/P QND Zoom H/P | QND Zoom H/P | 08800023200263 | On the market |
Similar devices
Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
- Greenton Ecolite IPL System by Greenton (London), Ltd.
- TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST by TRIMEDYNE, INC.
- Nuvo-Lase 660 Laser System by American Laser Medical
- MCL 29 DERMABLATE ERBIUM LASER SYSTEM by Aesculap-Meditec GmbH
- OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM by Summit Technology, Inc.
- NLITE SYSTEM by Icn Photonics, Ltd.
- ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY by Endo Lase, Inc.
- Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) by Rhein Laser Technologies Co., Ltd.
- OptiLite IX Laser Surgery Accessories by Convergent Laser Technologies
- Burane XL by Wavelight Laser Technologie AG