(176 days)
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No
The summary describes a laser system for oral soft tissue procedures and does not mention any AI or ML components or functionalities.
Yes
The device is intended for various medical procedures such as incision, excision, vaporization, and coagulation of oral soft tissue, which directly contribute to the treatment or management of medical conditions.
No
The device's intended uses, such as incision, excision, vaporization, and coagulation, along with specific indications for use like gingivectomy and frenectomy, describe surgical or therapeutic procedures, not diagnostic ones.
No
The device is described as a "LaserSystem" and its intended uses involve physical interaction with tissue (incision, excision, vaporization, ablation, coagulation), which are functions of a hardware device, not software alone.
Based on the provided information, the DENTEK LD 15 LaserSystem is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The listed uses (incision, excision, vaporization, ablation, coagulation in oral soft tissue) are all procedures performed directly on the patient's body. IVD devices, by definition, are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
- Lack of IVD-related information: The description does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD device.
Therefore, the DENTEK LD 15 LaserSystem is a medical device used for surgical procedures on oral soft tissue, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation and coagulation and in oral soft tissue.
Indications for Use:
- Soft Tissue
. gingivectomy
. gingival incisions and excisions
. tissue retraction for impressions
frenectomy
. treatment of aphthous ulcers
. excisional and incisional biopsies
. incising and draining of abscesses
. exposure of unerupted teeth
. hemostasis
Prescription Use (Per 21 CFR 801.109)
Product codes
GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized image of an eagle with three lines representing its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 21 1998
Mr. Michael Riel ·President DENTEK-Lasersystems Produktions Ges.m.b.H. Gasselberg 53-54, A-8564 Gaisfeld Austria
Re: K974057 DENTEK LD-15 Diode Laser System Trade Name: and Accessories Regulatory Class: II Product Code: GEX Dated: January 28, 1998 January 29, 1998 Received:
Dear Mr. Riel:
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 reqistration, 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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 - Mr. Riel
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.qov/cdrh/dsmamain.html",
Sincerely yours,
a 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
The following intended uses and indications for use will be included in the Operator's Manual.
Intended Uses:
The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation and coagulation and in oral soft tissue
Indications for Use:
- Soft Tissue
. gingivectomy
. gingival incisions and excisions
. tissue retraction for impressions
frenectomy ----------------------
. treatment of aphthous ulcers
. excisional and incisional biopsies
. incising and draining of abscesses
. exposure of unerupted teeth
. hemostasis
Prescription Use
(Per 21 CFR 801.109)
D. coole