← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K964076 # LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES (K964076) _Laserscope · GEX · Jan 8, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964076 ## Device Facts - **Applicant:** Laserscope - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Jan 8, 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 Laserscope Erbium:YAG Laser System and Accessories are indicated for use in procedures involving cutting (incision/excision), vaporizing and coagulating soft tissue. All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Clinical Applications: Dermatology/Plastic Surgery General Surgery (Soft Tissue) Genitourinary Gynecology ENT Soft Tissue Procedures Oral and Maxillofacial Surgery Ophthalmology Podiatry ## Device Story Moveable console containing power supplies, aiming laser, and Erbium:YAG treatment laser on solid optical deck; cooling mechanism for heat dissipation. User interface: softouch keypad with LCD display for parameter control. Delivery system: articulating arm with handpiece; interchangeable focusing adapters (1-5 mm spot sizes). Used in clinical settings (OR, clinic) by physicians for soft tissue surgery. Laser energy enables precise incision, excision, vaporization, and coagulation. Benefits: controlled tissue interaction, reduced thermal damage compared to other lasers, versatile surgical application. ## Clinical Evidence Bench testing only; no clinical data provided. Device conforms to 21 CFR 1040.10 and 1040.11 performance standards for medical laser systems. ## Technological Characteristics Erbium:YAG laser system; wavelength-based tissue interaction. Includes articulating arm, handpiece, and focusing adapters (1-5 mm). Cooling mechanism for heat dissipation. Console-based power supply. Conforms to 21 CFR 1040.10 and 1040.11. No software-based algorithmic control described. ## 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 - SEO Medical Trilase 2490 ## 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} K964076 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ## LASERSCOPE ERBIUM:YAG LASER SYSTEM AND ACCESSORIES **REGULATORY AUTHORITY:** Safe Medical Devices Act of 1990, 21 CFR 807.92 JAN 8 1997 **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 Erbium:YAG Laser System and Accessories **DEVICE COMMON NAME:** Erbium:YAG Laser System **DEVICE DESCRIPTION:** The Laserscope Erbium:YAG Laser System and Accessories consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical deck and a cooling mechanism to dissipate the heat generated by the system. A softouch keypad control panel with LCD displays enables the user to control the laser system operating parameters. The aiming beam is coincident with the Erbium:YAG beam and passes through an articulating arm. The aiming beam emerges at the distal end of a handpiece. Focusing handpiece adapters, which attach to the handpiece, are available in spot sizes of 1 - 5 mm. Laserscope Premarket Notification for Erbium:YAG Laser System and Accessories 10 {1} # SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2 ## DEVICE CLASSIFICATION: Erbium:YAG Laser Systems and Accessories have not been specifically classified; however Nd:YAG, CO₂, and Argon Surgical Lasers have been classified as Class II medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels. ## PERFORMANCE STANDARDS: All Laserscope Erbium:YAG Surgical Laser Systems and Accessories conform with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. ## INDICATION FOR USE STATEMENT: The Laserscope Erbium:YAG Laser System and Accessories are indicated for use in procedures involving cutting (incision/excision), vaporizing and coagulating soft tissue. All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Clinical Applications: - Dermatology/Plastic Surgery - General Surgery (Soft Tissue) - Genitourinary - Gynecology - ENT Soft Tissue Procedures - Oral and Maxillofacial Surgery - Ophthalmology - Podiatry Laserscope Premarket Notification for Erbium:YAG Laser System and Accessories {2} SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 3 COMPARISON WITH PREDICATE DEVICE: The Laserscope Erbium:YAG Laser System and Accessories is substantially equivalent to the SEO Medical Trilase 2490. The risks and benefits for the Laserscope Erbium:YAG Laser System and Accessories are comparable to the predicate device when used for similar clinical applications. Since the Laserscope Erbium:YAG Laser System and Accessories are 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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964076](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964076) **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