(550 days)
Not Found
Not Found
No
The summary describes a laser system with a microprocessor for control, but there is no mention of AI or ML capabilities for image processing, data analysis, or decision support.
Yes.
The device is intended to perform various surgical procedures and treatments for soft tissues, including for conditions like abscesses, ulcers, and periodontitis, which directly treat diseases or alter the structure or function of the body.
No
Explanation: The provided text describes the PerioLase Nd:YAG Dental Laser System as a device for surgical procedures such as ablating, incising, excising, vaporization, and coagulation of soft tissues. It outlines various oral-pharyngeal and other surgical indications. There is no mention of the device being used to diagnose conditions or capture diagnostic information. Its purpose is therapeutic intervention, not diagnosis.
No
The device description explicitly states it is a laser system consisting of a cabinet housing hardware components (laser head, power supply, cooling system, microprocessor) and a fiber optic delivery system. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the PerioLase Nd: YAG Dental Laser System is used for surgical procedures on soft tissues within the body (oral-pharyngeal, intraoral). It's used for ablating, incising, excising, vaporization, and coagulation.
- Lack of Specimen Analysis: There is no mention of the device analyzing any specimens taken from the patient. Its function is direct interaction with the patient's tissues.
Therefore, the PerioLase is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The following are the oral-pharngeal indications for use for which the device will be marketed: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingivaltooth mobility tooth mobility.
The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber optic delivery The device will be used in the following areas: general and cosmetic dentistry system. otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following is the additional oral-pharngeal indication for use for which the device will be marketed: Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse durations (100-650µsec). The laser consists of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral-pharngeal, intraoral soft tissue
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)
The new clinical outcome claim is based on human histological and radiographic data from a controlled prospective University-based clinical study.
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.
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This 510(K) Summary of safety and effectiveness for the Millennium Dental Technologies PerioLase Dental Laser This 310(K) Submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Millennium Dental Technologies, Inc. |
|---|---|
| Address: | 10945 South Street, Suite 104-A |
| Cerritos, CA 90703 | |
| Contact Person: | David M. Harris, Ph.D. |
| Telephone: | (562) 860-2908 - Phone |
| (562) 860-2429 - FAX | |
| Preparation Date: | January 01, 2003 |
| Device Trade Name: | PerioLase Dental Laser |
| Common Name: | Nd:YAG Pulsed Laser |
| Classification Name: | Instrument, Surgical, Powered, Laser |
| 79-GEX | |
| 21 CFR 878-48 | |
| Legally Marketed Predicate | |
| Device: | PerioLase Dental Laser |
| Description of the Millennium | |
| Dental Technologies PerioLase | |
| Dental Laser | The PerioLase is a FR Nd:YAG laser producing laser emission at |
| 1064nm with variable pulse durations (100-650µsec). The laser | |
| consists of two interconnected sections: The cabinet which houses | |
| the laser head, the power supply, the cooling system and the | |
| microprocessor with control panel; and the fiber optic delivery | |
| system. | |
| Clinical Performance Data: | The new clinical outcome claim is based on human histological and |
| radiographic data from a controlled prospective University-based | |
| clinical study. | |
| Summary Basis of Equivalence: | N/A |
1
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1/2
| Summary of Safety and Effectiveness Information PerioLase
Dental Laser System
Premarket Notification, Section 510(k) | MILLENNIUM DENTAL
TECHNOLOGIES, INC.
JANUARY 17, 2003 |
|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use: | The following are the oral-pharngeal indications for use
for which the device will be marketed:
Abscess Incision and Drainage
Apthous Ulcers Treatment
Biopsies Excision and Incision
Crown lengthening
Hemostatic assistance
Fibroma Removal
Frenectomy
Frenotomy
Gingival Incision and Excision
Gingivectomy
Gingivoplasty
Operculectomy
Oral Papillectomy
Tissue retraction for Impression
Vestibuloplasty.
Selective ablation of enamel (first degree) caries
Exposure of unerupted / partially erupted teeth
Implant recovery
Lesion (tumor) removal
Leukoplakia
Pulpotomy
Pulpotomy as adjunct to root canal therapy
Removal of filling material such as gutta percha or
resin as adjunct treatment during root canal re-
treatment
Sulcular debridement (removal of diseased or inflamed
soft tissue in the periodontal pocket) to improve
clinical indices including gingival index, gingivaltooth mobility tooth mobility. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2004
Millenium Dental Technologies, Inc. c/o David M. Harris, Ph.D. Bio-Medical Consultants, Inc. 4256 Heyer Avenue Castro Valley, California 94546
Re: K030290
Trade/Device Name: PerioLase Nd:YAG Dental Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 21, 2004 Received: April 27, 2004
Dear Dr. Harris:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rooduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - David M. Harris, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you'ls begal 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Melkersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number : K030290
PerioLase Nd:YAG Dental Laser System Device Name(s):
indications For Use:
The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber optic delivery The device will be used in the following areas: general and cosmetic dentistry system. otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following is the additional oral-pharngeal indication for use for which the device will be marketed:
- Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-. attachment to the root surface in the absence of long junctional epithelium.)
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkerson
I, Restorative. and Neurological Devices
Page_1 of
510(k) Number K030290