Identifiers
- 510(k) Number
- K102639 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 SL3 is a soft-tissue diode laser unit designed for use in dental procedures. This device functions as a desktop laser system to facilitate various soft-tissue applications.
The device is supplied as a desktop unit featuring battery operation, disposable fiber tips, and a wireless footpedal. It is authorized under FDA 510K clearance.
Frequently asked questions
What is the intended use of the SL3 laser system?
The SL3 is a diode laser unit specifically engineered for dental procedures involving soft tissue. It functions as a desktop system to facilitate various clinical soft-tissue applications.
How is the SL3 laser unit supplied to the clinician?
The device is supplied as a complete desktop unit. The system includes the main laser console, a wireless footpedal for operation, and disposable fiber tips for use during procedures.
Does the SL3 laser system require a power cord during use?
No, the SL3 is designed for battery operation. This allows for a cordless, desktop configuration that provides flexibility during dental soft-tissue procedures.
What is the regulatory status of the SL3 device?
The SL3 is authorized under FDA 510K clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: PDF SL3 User's Manual - User Manual Search Engine, Discus Dental LLC, DIODE LASER - Discus Dental - Dentistry Today, Discus Dental - LinkedIn
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102639 | Class II | Active |
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Manufacturer
- Manufacturer
- Discus Dental, LLC
Sources (1)
- FDA 510(k) K102639 24 fields · synced Sep 26, 2026