SMAXEL CO2 Surgical Laser System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Ids Ltd.
Identifiers
- 510(k) Number
- K180036 FDA 510(k)
- FDA Product Code
- ONG 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 SMAXEL CO₂ Surgical Laser System is a Powered Laser Surgical Instrument with Microbeam Fractional Output, classified as a Class II device under FDA regulations. It employs a carbon dioxide laser to deliver precise, fractional energy to tissue, enabling controlled ablation and collagen stimulation for surgical and resurfacing applications in general and plastic surgery.
This system is intended for use in sterile surgical environments and is supplied as a reusable medical device. It operates with multiple handpieces and pulse modes, including Smart Pulse, for fractional and surgical procedures. The device is authorised under FDA 510(k) clearance and complies with the Medical Device Directive (MDD), with registration numbers and specific FEI numbers listed for traceability. Storage and handling follow standard sterile instrument protocols.
Frequently asked questions
What types of surgical procedures is the SMAXEL CO₂ Surgical Laser System designed to assist with, and how does its fractional output technology help?
The SMAXEL CO₂ Surgical Laser System is designed for general and plastic surgery applications, delivering precise fractional energy to tissue for controlled ablation and collagen stimulation. Its microbeam fractional output allows for targeted treatment, enabling resurfacing procedures and surgical interventions with improved precision and reduced collateral damage to surrounding tissue.
Is the SMAXEL CO₂ Surgical Laser System intended for single-use or reusable applications, and what does this mean for maintenance and sterilization?
The SMAXEL CO₂ Surgical Laser System is supplied as a reusable medical device, meaning it is designed for repeated use in sterile surgical environments. This requires adherence to standard sterile instrument protocols for cleaning, sterilization, and maintenance between procedures to ensure safety and functionality.
What pulse modes are available on the SMAXEL CO₂ Surgical Laser System, and how might they be used in clinical practice?
The SMAXEL CO₂ Surgical Laser System includes multiple handpieces and operates with various pulse modes, including Smart Pulse, which is tailored for fractional and surgical procedures. Smart Pulse likely optimizes energy delivery for specific applications, such as precise tissue ablation or collagen remodeling, depending on the clinical need.
How can I verify the regulatory compliance and traceability of the SMAXEL CO₂ Surgical Laser System, particularly for purchasing or inventory purposes?
The system is authorized under FDA 510(k) clearance (K180036) and complies with the Medical Device Directive (MDD). Traceability is supported by multiple FEI numbers (e.g., 3006716777, 3043047259) and registration numbers listed in the specifications. These identifiers can be used to confirm authenticity and compliance during procurement or inventory management.
What special considerations should be taken into account when storing or handling the SMAXEL CO₂ Surgical Laser System?
Since the SMAXEL CO₂ Surgical Laser System is intended for use in sterile surgical environments and is reusable, storage and handling must follow standard sterile instrument protocols. This includes proper cleaning, sterilization, and storage conditions to maintain device integrity and prevent contamination before and after use.
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: SMAXEL — Fractional CO₂ laser | IDS Lasers, Smaxel - Ids, Co2 | Ids, SMAXEL — Fractional CO₂ laser | IDS Lasers
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180036 | Class II | Active |
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Manufacturer
- Manufacturer
- Ids Ltd.
- FDA Applicant
- Ids, Ltd.
Sources (2)
- FDA 510(k) K180036 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026