FOTONA SKINSCAN

K970757 · Medical Laser Solutions · GEX · May 9, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970757
• Device Name: FOTONA SKINSCAN
• Applicant: Medical Laser Solutions
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fotona Skinscan system is a microprocessor controlled device which generates precisely defined patterns on skin tissue in an automated sequence to increase uniformity and ease of treatment when used in conjunction with a host Skinlight system.

Device Story

Microprocessor-controlled accessory for Fotona Skinlight laser; generates automated, uniform laser patterns on skin tissue. Comprises scanner handpiece (with smoke evacuation/distance gauge), scanner head (mirrors/optics), and electronic control box (mirror control/laser interface). Integrated with host laser; host recognizes accessory presence to enable scanner-specific menu modes. Used by clinicians in dermatological settings to improve treatment uniformity and ease of operation. Output is controlled laser beam delivery in defined patterns. Benefits include increased procedural consistency and simplified laser application.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Microprocessor-controlled laser scanning accessory. Components: scanner handpiece, scanner head with mirrors/optics, electronic control box. Connectivity: physical cable interface to host laser system. Software: embedded firmware for scanner-specific menu modes and mirror control.

Indications for Use

Indicated for use as an accessory to the Fotona Skinlight laser system to generate automated, uniform laser patterns on skin tissue.

Regulatory Classification

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.

Predicate Devices

• Coherent CPG system (K946304)

Submission Summary (Full Text)

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Premarket notification - Fotona Skinlight Laser
K970757
MAY 9, 1997

# Appendix E : Summary of Safety and Effectiveness Data

## General Information and Description

The Fotona Skinscan system is a microprocessor controlled device which generates precisely defined patterns on skin tissue in an automated sequence to increase uniformity and ease of treatment when used in conjunction with a host Skinlight system.

The Fotona Skinscan system is designed as an accessory for use with the Fotona Skinlight laser system. Skinscan is functionally integrated to the host laser system. When the scanner head is attached to the articulated arm and the scanner cable is connected, the host laser system recognizes the presence and activation of the accessory and permits activation of the scanner specific modes which are programmed into the host at time of installation of the scanner accessory. In these modes scanner settings can be selected from an easy-to-read menu. When the operator reverts to use of the standard dermatological handpiece, these settings are not accessible. When the scanner is connected and a scanner sub-menu is selected the system automatically initiates for scanner operation.

The Skinscan system is designed with 3 major sub-systems

a) A scanner handpiece comprising smoke evacuation components and distance gauge components.

b) A scanner head, containing scanning mirrors and imaging optics.

c) An electronic control box containing scanning mirror control and laser interface circuitry.

No accessories are available for use with Skinscan

## Summary of Substantial Equivalence

Fotona believes that its Skinscan system is substantially equivalent to the Coherent CPG system, previously cleared under K 946304.

Fotona Skinlight 510(k) submission. erb510k2.doc

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Premarket notification : Fotona Skinlight Laser

Technologically, the predicate has identical characteristics to Skinscan, both comprising an electronic control module, a scanner head and a scanner handpiece.

Both devices act as accessories to host laser systems and are not themselves active components.

It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.

Fotona Skinlight 510(k) submission, erb510k2.doc