← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K971065 # DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES (K971065) _Xintec Corporation · GEX · Jun 17, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K971065 ## Device Facts - **Applicant:** Xintec Corporation - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Jun 17, 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 Dentica Pulsed Nd:YAG Laser System and accessories is indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue and cartilage. Soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands. Specific surgical specialties include: - Dentistry - Laser Curettage; Gingivectomy; Gingivoplasty; Incision and Excision - Oral Surgery - Frenectomy; Incisional and Excisional Biopsy; Incisional and Excisional aphous ulcers; Incision of infection when used with antibiotic therapy; Excision and ablation of benign and malignant lesions and conditions; Homeostasis; Operculectomy, and Crown lengthening. - Ear Nose & Throat (ENT) - Head and Neck Surgery - Thoracic Surgery - Neurology (homeostasis only) - Dermatology - Plastic Surgery - General Surgery ## Device Story Dentica Pulsed Nd:YAG Laser System; surgical laser for soft tissue and cartilage management. Inputs: electrical power; outputs: pulsed Nd:YAG laser energy. Used in clinical settings (dentistry, oral surgery, ENT, general surgery, etc.) by trained physicians/dentists. Laser energy performs incision, excision, ablation, and coagulation (homeostasis) of soft tissues (skin, muscle, mucous membranes, etc.). Benefits include precise tissue removal and controlled bleeding during surgical procedures. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Pulsed Nd:YAG laser system; intended for soft tissue and cartilage surgery. Energy source: electrical power converted to pulsed laser output. Form factor: system with accessories. No software or connectivity 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. ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Marilyn M. Chou, Ph.D. Executive Vice President Xintec Corporation 900 Alice Street Oakland, California 94607 JUN 17 1997 Re: K971065 Trade Name: Dentica Pulsed Nd:YAG Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: March 22, 1997 Received: March 24, 1997 Dear Dr. Chou: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 device, 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 device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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 device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device 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 device, 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, ![img-0.jpeg](img-0.jpeg) 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} # 510(k) Premarket Notification #K97-1065 ## Dentica (tm) Pulsed Nd:YAG Laser System and Accessories ### Indications For Use The Dentica Pulsed Nd:YAG Laser System and accessories is indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue and cartilage. Soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands. Specific surgical specialties include: - Dentistry - Laser Curettage; Gingivectomy; Gingivoplasty; Incision and Excision - Oral Surgery - Frenectomy; Incisional and Excisional Biopsy; Incisional and Excisional aphous ulcers; Incision of infection when used with antibiotic therapy; Excision and ablation of benign and malignant lesions and conditions; Homeostasis; Operculectomy, and Crown lengthening. - Ear Nose & Throat (ENT) - Head and Neck Surgery - Thoracic Surgery - Neurology (homeostasis only) - Dermatology - Plastic Surgery - General Surgery ![img-1.jpeg](img-1.jpeg) ![img-2.jpeg](img-2.jpeg) --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K971065](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K971065) **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. 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