DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES

K971065 · Xintec Corporation · GEX · Jun 17, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971065
• Device Name: DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES
• Applicant: Xintec Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• 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.

Indications for Use

Indicated for incision, excision, ablation, and coagulation (homeostasis) of soft tissue and cartilage in patients undergoing surgical procedures in dentistry, oral surgery, ENT, head and neck, thoracic, neurology (homeostasis only), dermatology, plastic, and general surgery.

Regulatory Classification

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)

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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# 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