(207 days)
No
The device description focuses on laser technology and adjustable parameters, with no mention of AI or ML capabilities.
Yes
The device is described as performing various soft tissue dental applications, including incision, excision, vaporization, ablation, and coagulation of oral soft tissues, and lists specific indications such as fibroma removal, frenectomy, gingivectomy, and treatment of canker sores, which are all therapeutic interventions.
No
The device description and intended use describe procedures for treatment (incise, excise, vaporize, coagulate, ablate, removal of tissue, etc.), not diagnosis.
No
The device description clearly outlines hardware components such as a laser diode system, fiberoptic cable, and handpiece, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EZLase™ dental diode laser system is used for surgical procedures on oral soft tissues. It directly interacts with the patient's body to incise, excise, vaporize, coagulate, and ablate tissue.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the body. Its function is entirely focused on treating tissue in situ.
Therefore, the EZLase™ dental diode laser system falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dental Soft Tissue Indications for:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty
Laser Periodontal procedures, including:
Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket
Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
Product codes
79 GEX
Device Description
The EZLase dental diode laser system may be used to perform various soft tissue dental applications. The system uses advanced laser technology to incise, excise, vaporize, coagulate and ablate intra-oral soft tissues. A Gallium Aluminum Arsenide (GaAlAs) and/or an Indium Gallium Arsenide Phosphorous solid-state laser diode emit infrared laser energy to the various oral soft tissues targeted during procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissues, marginal and inter-dental gingival and epithelial lining of free gingiva, periodontal pocket
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)
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.
0
| Regulatory
Authority: | Safe Medical Devices Act of 1990,
21 CFR 807.92 | K061898 | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------|--------|------|
| Company: | BioLase Technology, Inc.
4 Cromwell
Irvine, CA 92618 | | JAN 26 | 2007 |
| Contact: | Ms. Ioana M. Rizoiu
BioLase Technology, Inc.
4 Cromwell
Irvine, CA 92618
Tel: (949) 226 8144 Fax: (949) 273 6680 | | | |
| Trade Name: | EZLase TM | | | |
| Common Name: | Dental diode laser | | | |
| Classification Name: | Surgical laser instrument | | | |
| Classification Code: | 79 GEX | | | |
| Equivalent Devices: | | LaserSmileTM | | |
| BioLase Technology, Inc. | | | | |
| Hoya ConBio, Inc. | | LVI lase | | |
| Hoya ConBio, Inc. | | DioDent II | | |
510(k) Summary of Safety and Effectiveness Information
Device Description:
The EZLase™ dental diode laser system may be used to perform various soft tissue dental applications. The system uses advanced laser technology to incise, excise, vaporize, coagulate and ablate intra-oral soft tissues. A Gallium Aluminum Arsenide (GaAlAs) and/or an Indium Gallium Arsenide Phosphorous solid-state laser diode emit infrared laser energy to the various oral soft tissues targeted during procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.
1
K061898
Indications for Use:
Dental Soft Tissue Indications for:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty
Laser Periodontal procedures, including:
Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket
Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
2/3
2
15061898
Contraindications:
- 6.6.1 All clinical procedures performed with EZLase™ must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea, an immune system deficiency and other such conditions. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.
Substantial Equivalence:
There are no unique applications, indications, materials or specifications presented herein. All the submitted indications for use retain the same meaning as their equivalent indications cleared by the FDA in the following 510k clearances: K030539 for LaserSmile™, K041721 for LVI Lase and K050274 for DioDent II.
Conclusion:
EZLase™ is substantially equivalent to dental products previously cleared for marketing. EZLase™ performs the same indications for use through the same mechanism as the other cleared devices. Evidence of equivalence has been demonstrated through the following:
- . Equivalent performance specification
- . Equivalent intended use
- Feature comparison table
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolase Technology Inc. % Ms. Ioana M. Rizoiu VP. Clinical Research and Development 4 Cromwell Irvine, California 92618
JAN 2 6 2007
Re: K061898 Trade/Device Name: EZLase™ 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: December 19, 2006 Received: December 20, 2006
Dear Ms. Rizoiu:
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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Ms. Ioana M. Rizoiu
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Hyatt Rhoden
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K061898
EZLase™M Device Name:
Indications for Use:
Dental Soft Tissue Indications for:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty
Laser Periodontal procedures, including:
Laser soft tissue curettage Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
Stupt Rhodes for MXM
Division Sign-Off
Division of General, Restorative and Neurological Devices
(k) Number K 06 1898
1/2
6
Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
Stephen Rhodes for mxm
(Mission Sign-Off)
Wision of General, Restorative nd Neurological Devices
Number KOC 1898