← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K971912 # PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES (K971912) _Xintec Corporation · GEX · Nov 3, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K971912 ## Device Facts - **Applicant:** Xintec Corporation - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Nov 3, 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 Protégé and Protégé LP Er: YAG Laser Systems and accessories are indicated for incision/excision, ablation, and coagulation (hemostasis) of soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, mucous membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include: Dentistry Soft tissue (incision, excision, ablation and coagulation) Dermatology and Plastic Surgery Epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers Oral/Maxillofacial (benign oral tumor, oral and glossal lesions and gingivectomy) Ear Nose & Throat (ENT), Head and Neck Surgery GI, GU, GYN and Pulmonary Surgery - Orthopedic Surgery - Thoracic Surgery - Ophthalmology - Podiatry - General Surgery ## Device Story Protégé and Protégé LP are Er:YAG laser systems; utilize erbium-doped yttrium aluminum garnet crystal as gain medium; emit laser energy for surgical soft tissue management. Functions: incision, excision, ablation, and coagulation (hemostasis). Operated by physicians/surgeons in clinical/surgical settings. Laser energy interacts with soft tissue (skin, muscle, mucous membranes, organs, glands) to achieve desired surgical effect. Benefits: precise tissue removal/modification with concurrent hemostasis. Device includes laser console and accessories. ## Technological Characteristics Er:YAG (Erbium-doped Yttrium Aluminum Garnet) laser system; solid-state laser technology; used for soft tissue surgical applications (incision, excision, ablation, coagulation). ## 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. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV - 3 1997 Marilyn M. Chou, Ph.D. Executive Vice President Xintec Corporation 900 Alice Street Oakland, California 94607 Re: K971912 Trade Name: Protégé and Protégé LP Er: YAG Laser Systems and Accessories Regulatory Class: II Product Code: GEX Dated: August 1, 1997 Received: August 5, 1997 Dear Dr. Chou: We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ Page 2 - Marilyn M. Chou, Ph.D. This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market. If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ .. L ## 510(k) Number: #K971912 Device Name: Protégé (tm) Er: Y AG Laser Systems and Accessories Indications For:Use: The Protégé and Protégé LP Er: YAG Laser Systems and accessories are indicated for incision/excision, ablation, and coagulation (hemostasis) of soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, mucous membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include: Dentistry Soft tissue (incision, excision, ablation and coagulation) Dermatology and Plastic Surgery Epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers Oral/Maxillofacial (benign oral tumor, oral and glossal lesions and gingivectomy) Ear Nose & Throat (ENT), Head and Neck Surgery GI, GU, GYN and Pulmonary Surgery - Orthopedic Surgery - Thoracic Surgery - Ophthalmology - Podiatry - General Surgery Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division Sign-Off) (Division of General Restorative Device 510(k) Number Prescription Use (21 CFR 801.109) OR Over-The-Counter Use --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K971912](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K971912) **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