Spectra SP II, Spectra Denta II
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091320 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 Spectra SP II and Spectra Denta II are CO₂ laser surgical instruments (10.6 µm wavelength) designed for soft tissue surgery. Classified under the GEX product code as powered laser surgical devices, they are intended for use in general and plastic surgery procedures. These systems employ a DC-excited sealed-off CO₂ tube within the console to generate laser output, supported by integrated cooling and power supply systems. The devices operate in multiple modes, including Continuous Wave, Char-Free, and Super Pulse, to facilitate precise tissue ablation or coagulation.
The Spectra SP II and Spectra Denta II are supplied as complete systems, including a console, articulated arm, footswitch, protective goggles, and interchangeable handpieces. They are intended for single-use or reusable applications in clinical settings, with sterility maintained through manufacturer-provided packaging or reprocessing protocols as specified. These devices are not MRI-compatible and must be used in environments where electromagnetic interference is controlled. Authorized for use in the United States under FDA 510(k) clearance (K091320), they comply with Class II special controls for powered laser surgical instruments.
Frequently asked questions
What types of surgical procedures are these CO₂ laser systems primarily designed for, and how do their operating modes help in those procedures?
The Spectra SP II and Spectra Denta II are designed for soft tissue surgery in general and plastic surgery procedures. Their operating modes—Continuous Wave, Char-Free, and Super Pulse—allow clinicians to tailor the laser output for precise tissue ablation (removal) or coagulation (sealing blood vessels). For example, Continuous Wave provides steady energy for deeper cuts, while Char-Free minimizes charring for cleaner incisions, and Super Pulse delivers controlled bursts for reduced thermal damage.
Are these devices meant for single-use or can they be reused in a clinical setting, and what does that mean for maintenance?
The Spectra SP II and Spectra Denta II are designed for both single-use and reusable applications, depending on the clinical setting and manufacturer guidelines. If reused, they must undergo strict reprocessing protocols (cleaning, sterilization, and inspection) as specified by Lutronic to ensure safety and performance. Single-use components like handpieces or packaging should be discarded after one procedure, while reusable parts like the console or articulated arm require proper maintenance to prevent contamination or damage.
What safety precautions should be taken when using these lasers, particularly regarding electromagnetic interference and MRI compatibility?
These devices are not MRI-compatible, meaning they should never be used in or near MRI environments due to potential electromagnetic interference risks. Additionally, they must be operated in controlled settings where electromagnetic interference is minimized to avoid disrupting other medical equipment. Protective goggles are provided to shield clinicians’ eyes during use, and the footswitch allows hands-free operation for better precision during procedures.
What key components come included with the Spectra SP II and Spectra Denta II systems, and how does the articulated arm contribute to usability?
The systems are supplied as complete packages, including a console (with CO₂ laser tube, cooling, and power supply), an articulated arm for flexible positioning, a footswitch for hands-free control, protective goggles, and interchangeable handpieces. The articulated arm’s design allows clinicians to direct the laser beam with precision, adjusting angles and reach to access difficult or delicate areas during surgery without repositioning the patient or console.
How do I determine if a specific Spectra model (SP II vs. Denta II) is right for my practice, and are there differences in their intended applications?
While both models share the same core technology (CO₂ laser with identical operating modes), the Spectra Denta II is specifically tailored for dental and maxillofacial procedures, whereas the Spectra SP II is optimized for broader soft tissue surgery in general and plastic surgery. The choice depends on your practice focus—dental applications may prioritize ergonomic handpieces or smaller footprints, while general surgery may benefit from the SP II’s versatility across larger procedures. Consult Lutronic’s documentation for model-specific details.
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: K091320 FDA 510 (k) - SPECTRA SP II | Lutronic Corporation, SPECTRA SP II, SPECTRA DENTA II (K091320) — FDA 510(k) | Innolitics, PDF ;ji)-V D o - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091320 | Class II | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
Sources (1)
- FDA 510(k) K091320 24 fields · synced Sep 20, 2026