8-WATT Pulsed Dental Laser System
510(k) K930789
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930789 | Date21 May 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The 8-Watt Pulsed Dental Laser System is a powered laser surgical instrument designed for dental procedures. It emits controlled laser energy to perform soft tissue treatments, including gingival contouring, periodontal therapy, and cavity preparation. The device operates within the classification of powered laser surgical instruments, as defined by regulatory standards, and is intended for use in dental settings where precision and minimal tissue trauma are required.
This system is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K930789) with a classification under product code GEX. It was granted Substantially Equivalent (SESE) status by the FDA’s General and Plastic Surgery advisory committee in 1993. The device is not specified as single-use or sterile upon delivery, and no MRI safety information is provided in the regulatory records. Storage and handling instructions are not detailed in the available data.
Other devices from Sunrise Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What dental procedures is the 8-Watt Pulsed Dental Laser System designed for?
This laser system is specifically engineered for soft tissue dental procedures, including gingival contouring (shaping gum tissue), periodontal therapy (treating gum disease), and cavity preparation (preparing tooth surfaces for fillings). The controlled laser energy minimizes trauma to surrounding tissues, making it ideal for precision work in dental settings.
Is the 8-Watt Pulsed Dental Laser System single-use or reusable?
The device is supplied as a reusable medical instrument. It is not intended for single-use applications, and no sterility guarantees are provided at the time of delivery. Proper cleaning, maintenance, and sterilization protocols must be followed by the dental facility to ensure safe reuse.
What regulatory status does this laser system hold?
The 8-Watt Pulsed Dental Laser System holds FDA 510(k) clearance under the product code GEX, with a classification as a powered laser surgical instrument. It was granted Substantially Equivalent (SESE) status by the FDA’s General and Plastic Surgery advisory committee in 1993, meaning it was deemed comparable to legally marketed predecessors.
Are there any special storage or handling instructions for this device?
The available regulatory records do not specify detailed storage or handling instructions for this laser system. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for maintenance and sterilization to preserve functionality and ensure patient safety.
Does this laser system have any limitations regarding MRI compatibility?
The regulatory records for this device do not provide explicit MRI safety information. Clinicians should consult the manufacturer’s current documentation or technical specifications to determine compatibility with MRI environments, as laser systems may contain metallic or electronic components that could pose risks in magnetic fields.