← Product Code [GEX](/productcode/GEX) · K970157 # LASERSCOPE AUTOMATIC EYE PROTECTION FILTER (K970157) _Laserscope · GEX · Apr 7, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K970157 ## Device Facts - **Applicant:** Laserscope - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** Apr 7, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use The Laserscope Automatic Eye Protection Filter is intended to be used in conjunction with an endoscope or microscope for all cleared Laserscope indications for the Orion and Aura Surgical Laser Systems. ## Device Story Mechanical shutter system; moves protective filters into line of view before laser emission; activated via laser foot pedal; provides unobstructed view when laser inactive. Connects to laser via electrical cable; monitored by laser system microprocessor. User must attach filter or disable feature via control panel to enable laser beam. Used in clinical settings (OR/clinic) by physicians; protects user eyes from laser radiation during endoscopic or microscopic procedures. ## Clinical Evidence No clinical data provided; safety and effectiveness based on substantial equivalence to predicate device and mechanical design. ## Technological Characteristics Mechanical shutter assembly; electrical interface to laser control board; microprocessor-monitored; software-controlled activation/disablement. Complies with 21 CFR 1040.10 and 1040.11 for medical laser systems. ## 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 - Automatic Eye Protection Filter (integral part of Laserscope 800 Series 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. > > 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} APR - 7 1997 K970157 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE AUTOMATIC EYE PROTECTION FILTER ## REGULATORY AUTHORITY: Safe Medical Devices Act of 1990, 21 CFR 807.92 ## COMPANY NAME/CONTACT: Lisa McGrath Laserscope 3052 Orchard Drive San Jose, CA 95134-2011 Phone: 408 943-0636 FAX: 408 943-1454 ## DEVICE TRADE NAME: Laserscope Automatic Eye Protection Filter ## DEVICE COMMON NAME: Automatic Eye Protection Filter ## DEVICE DESCRIPTION: The Laserscope Automatic Eye Protection Filter (AEPF) is a mechanical shutter that moves protective filter(s) into the line of view before the laser beam is emitted from the laser aperture. The AEPF is automatically activated when the laser foot pedal is pressed. The AEPF provides the user with an unobstructed view of the target when the laser is not activated. The AEPF is connected to the laser by an electrical cable which interfaces with the main control board. The drive/control electronics are monitored by the laser system's microprocessor. The software default is to ask the user if they want to disable the Automatic Eye Protection Filter. In order to activate the laser beam, the user must attach the Automatic Eye Protection Filter or disable the feature through the laser's control panel if they do not plan to utilize the device. 000009 Laserscope Premarket Notification for Automatic Eye Protection Filter {1} SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2 DEVICE CLASSIFICATION: To the best of our knowledge, Automatic Eye Protection Filters have not been specifically classified; however, the surgical lasers for which the are intended have been classified as Class II medical devices by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels. PERFORMANCE STANDARDS: The Laserscope Orion and Aura Surgical Laser Systems conform with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. Laserscope is unaware of any specific standards for Automatic Eye Protection Filters. INDICATION FOR USE STATEMENT: The Laserscope Automatic Eye Protection Filter is intended to be used in conjunction with an endoscope or microscope for all cleared Laserscope indications for the Orion and Aura Surgical Laser Systems. COMPARISON WITH PREDICATE DEVICE: The Laserscope Automatic Eye Protection Filter is substantially equivalent (identical) to the Automatic Eye Protection Filter which is an integral part of the Laserscope 800 Series Surgical Laser System. The risks and benefits for the Laserscope Automatic Eye Protection Filter are comparable to the predicate device when used for similar clinical applications. Since the Laserscope Automatic Eye Protection Filter is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale. 00C010 Laserscope Premarket Notification for Automatic Eye Protection Filter --- **Source:** [https://fda-staging.innolitics.com/device/K970157](https://fda-staging.innolitics.com/device/K970157) **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