← Product Code [GEX](/productcode/GEX) · K960821

# SLT FUMICH PROBE GUIDE (K960821)

_Surgical Laser Technologies, Inc. · GEX · May 16, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K960821

## Device Facts

- **Applicant:** Surgical Laser Technologies, Inc.
- **Product Code:** [GEX](/productcode/GEX.md)
- **Decision Date:** May 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

The SLT Fumich Probe Guide is intended to be used as an accessory to the SLT Laser Multidimensional Fiber Delivery System to facilitate the location of tissue for contact with a laser probe.

## Device Story

Accessory for SLT Laser Multidimensional Fiber Delivery System; consists of 4-inch PVC tubing with adjustable 2-pronged distal fork and proximal silicone connector; facilitates laser fiber placement; user slides distal fork onto tissue to stabilize; laser fiber threaded through lumen for direct tissue contact; used by clinicians in surgical settings; ensures precise probe-to-tissue contact for coagulation and vaporization; benefits patient by improving accuracy of laser delivery.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Materials: PVC tubing, silicone connector. Form factor: 4-inch length, 2-pronged distal fork. Sterilization: Sterile, single-use.

## Regulatory Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

## Reference Devices

- Sharplan 1100 CO2 surgical laser system

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
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K960821
MAY 16 1996

# SLT FUMICH PROBE GUIDE 510K SUMMARY

## Device Description:

The SLT Fumich Probe Guide geometry consists of PVC tubing with an adjustable sleeve being a 2-pronged fork on the distal end and a silicone connector on the proximal end of this tubing. Total length of this is approximately 4 inches. The distal end configuration is designed to slide onto tissue and stabilize this tissue. Laser fiber is threaded through the lumen of this guide with a probe at the end of the fiber for direct contact with tissue. Therefore, this configuration allows the user to know where the tissue and the probe are making contact and facilitates contact of the probe to tissue.

## Equivalency:

The SLT Fumich Probe Guide is designed to be used with the distal end of the SSRH8 hand-piece. This hand-piece is inserted through the proximal end of the Fumich Probe Guide; prior to use, a probe can be threaded onto that hand-piece and then withdrawn through the guide so that the guide can be first placed on tissue locating the tissue for contact with the probe. This accessory to the SLT Laser Multidimensional Fiber Delivery System is similar to the CO2 laser arm distal end that incorporates the tissue stabilizer or backstop such as that for the Sharplan 1100 CO2 surgical laser system. CO2 lasers have this guide to facilitate the tissue fiber location for assuring the location of the coagulation and vaporization of tissue.

## Conclusion:

The SLT Fumich Probe Guide will be provided as a sterile single use only accessory to the SLT Multidimensional Fiber Delivery System.

Summary Reference 6

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**Source:** [https://fda-staging.innolitics.com/device/K960821](https://fda-staging.innolitics.com/device/K960821)

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