(85 days)
Not Found
Not Found
No
The provided text describes a laser system for surgical procedures and does not mention any AI or ML capabilities.
Yes.
The device is indicated for various surgical procedures such as incision/excision, ablation, and coagulation of soft tissue and cartilage for different medical specialties, which are therapeutic actions.
No
The Dentica Pulsed Nd: YAG Laser System is indicated for surgical procedures like incision/excision, ablation, and coagulation, not for diagnosing conditions.
No
The device description explicitly states it is a "Pulsed Nd: YAG Laser System," which is a hardware device used for surgical procedures. The intended use also describes surgical applications involving physical interaction with tissue.
Based on the provided information, the Dentica Pulsed Nd: YAG Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Dentica Laser System's Intended Use: The Dentica Laser System is used for surgical procedures performed directly on the patient's body (in vivo). Its purpose is to incise, excise, ablate, and coagulate soft tissue and cartilage.
The description clearly indicates a surgical device used for treatment and manipulation of tissues within the body, not for testing samples outside the body.
N/A
Intended Use / 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. Ivmph 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
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and cartilage, skin, subcutaneous tissue, striated and smooth muscle, cartilage, mucous membrane, Ivmph vessels and nodes, organs and glands.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is in black and white.
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
JIN : 7 1997
参
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 Practive 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,
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. Ivmph 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
(Division Sign-03)
Division of General Restoration Devices
510(k) Number
69 71065
Prescription Use
(Per 21 CFR 801.109)
General Surgery