Fiberoptic Collimating Handpiece
by Dawn Laser Technology, Inc. 510(k)
Active
510(k) K854134
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854134 | Date7 Feb 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 19 Sep 2026
The Fiberoptic Collimating Handpiece is a powered laser surgical instrument designed for use in general and plastic surgery procedures. It delivers laser energy through an optical fiber, directing it in a collimated beam for precise tissue interaction during surgical applications.
This device is supplied as a reusable medical instrument and has been cleared under FDA 510(k) with the reference number K854134. It falls under the product code GEX and was determined to be substantially equivalent to a predicate device, with clearance granted on February 7, 1986. No specific sterility or MRI safety information is provided in the available data.
Questions
AI-generated answers, 19 Sep 2026
What types of surgical procedures is this fiberoptic collimating handpiece designed for?
This device is specifically designed for use in general and plastic surgery procedures. It delivers laser energy through an optical fiber in a collimated beam, allowing for precise tissue interaction during surgical applications.
Is this handpiece intended for single-use or can it be reused?
The Fiberoptic Collimating Handpiece is supplied as a reusable medical instrument. It is not intended for single-use, though proper cleaning, sterilization, and maintenance procedures must be followed to ensure safe reuse.
How was the regulatory clearance for this device determined?
The device was cleared under the FDA’s 510(k) program as substantially equivalent (SESE) to a predicate device, with clearance granted on February 7, 1986. The review was conducted under the General, Plastic Surgery advisory committee (SU) and falls under product code GEX.
Is there any information provided about sterility or MRI safety for this handpiece?
The available data does not specify any details regarding sterility or MRI safety for this device. Users should follow manufacturer guidelines for handling and storage to ensure safe use.
What is the manufacturer’s address for this device?
The manufacturer, Dawn Laser Technology, Inc., is located at 718 Willowglen Rd., Santa Barbara, CA 93105, United States. This address is provided in the regulatory submission records.