OPUSDUO - Opus Spectrum
FDA 510(k)Class II (US FDA 510(k))
by Lumenis Inc.
Identifiers
- 510(k) Number
- K040270 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- Models / Variants
- Opusduo FDA 510(k)Opusduo E FDA 510(k)Opusduo Ec FDA 510(k)Opus 20 FDA 510(k)Opus Spectrum 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 OpusDuo; OpusDuo E; OpusDuo EC; Opus 20; Opus Spectrum are Powered Laser Surgical Instruments (21 CFR 878.4810) designed for precise tissue ablation, coagulation, and vaporisation in surgical procedures. These devices utilise laser technology to deliver controlled energy for applications in general and plastic surgery, including dermatological and soft-tissue treatments.
These instruments are supplied as reusable medical devices, intended for use in sterile operating environments. They are classified under General & Plastic Surgery and have received FDA 510(k) clearance (K040270) as substantially equivalent to predicate devices. No specific MRI safety or single-use requirements are noted in the regulatory submission.
Frequently asked questions
What are the OpusDuo and Opus Spectrum devices used for?
These are powered laser surgical instruments designed for precise tissue ablation, coagulation, and vaporization in surgical procedures, including applications in general and plastic surgery, dermatological and soft-tissue treatments.
Are these devices single-use or reusable?
The OpusDuo and Opus Spectrum devices are supplied as reusable medical instruments intended for use in sterile operating environments.
What regulatory status do these devices have?
These devices have received FDA 510(k) clearance (K040270) as substantially equivalent to predicate devices under the General & Plastic Surgery classification.
Are there specific MRI safety requirements for these devices?
No specific MRI safety requirements are noted in the regulatory submission for these devices.
What models are included in the OpusDuo and Opus Spectrum device family?
The device family includes OpusDuo, OpusDuo E, OpusDuo EC, Opus 20, and Opus Spectrum models.
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: Opusduo; Opusduo E; Opusduo Ec; Opus 20; Opus Spectrum, PDF OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS… - FDA.report, OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM 510 (k) K040270 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040270 | Class II | Active |
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Manufacturer
- Manufacturer
- Lumenis Inc.
- FDA Applicant
- Lumenis, Ltd.
Sources (1)
- FDA 510(k) K040270 24 fields · synced Sep 19, 2026