← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K970757 # FOTONA SKINSCAN (K970757) _Medical Laser Solutions · GEX · May 9, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970757 ## Device Facts - **Applicant:** Medical Laser Solutions - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** May 9, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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. ## 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. ## Predicate Devices - Coherent CPG system ([K946304](/device/K946304.md)) ## 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. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 {1} 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970757](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970757) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com