(81 days)
Not Found
No
The summary describes a laser system with adjustable power and pulse width, but there is no mention of AI or ML in the device description, intended use, or any other section.
Yes
The device is used for laser-assisted teeth whitening/bleaching, which is a therapeutic procedure aimed at improving the appearance of teeth. It emits laser energy to targeted oral tissues, indicating a direct interaction with the body for treatment purposes.
No
The device uses laser energy for teeth whitening and bleaching and to treat oral soft tissues. Its function is to perform a therapeutic procedure (whitening/bleaching and treating tissue), not to diagnose a condition.
No
The device description explicitly details hardware components such as a laser diode, 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:
- Intended Use: The intended use is for "Light activation for bleaching materials for teeth whitening" and "Laser-assisted whitening/bleaching of teeth." These are procedures performed directly on the patient's teeth, not on samples of biological material outside the body.
- Device Description: The device description details a laser system that emits energy to oral soft tissues and teeth. This is a therapeutic or procedural device, not a device used to analyze samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
In summary, the exlase™ dental diode laser system is a medical device used for dental procedures, specifically teeth whitening and bleaching. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device may be used for the following indications:
- Light activation for bleaching materials for teeth whitening
- Laser-assisted whitening/bleaching of teeth
Product codes
GEX
Device Description
The exlase™ dental diode laser system is currently used to perform various and The system uses advanced laser technology to dealer with a many and the Samment works of the Mas An Indium Gallium Arsenide Phosphorus solid-state laser diode emits 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, teeth
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)
K061898, K003385, K993002, K050824, K072106, K060114
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
CONFIDENTIAL
.082938 Pa
Biolase Technology, Inc. Special 510(k) Summary Statement ezlase™ Expanded Indications for Use
| | 510(k) Summary
(As required by 21CFR807.92) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | October 1, 2008 |
| | DEC 22 2008 |
| Company: | Biolase Technology, Inc.
4 Cromwell
Irvine, CA 92618
Tel: (949) 361-1200
Fax: (949) 273-6680 |
| Contact: | Ms. Ioana M. Rizoiu
VP, Clinical R&D
Tel: (949) 226-8144
email: irizoiu@biolase.com |
| Trade Name: | ezlase™ |
| Common Name: | Dental Diode Laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX, a Class II device |
| Predicate Devices: | TwilightTM
Biolase Technology, Inc
Ceralas D Diode Laser Systems
Ceramoptic, Inc. (Biolitec, Inc.)
VectraTM
Xintec Corp., DBA Convergent Laser Technologies |
DEVICE DESCRIPTION:
The exlase™ dental diode laser system is currently used to perform various and The system uses advanced laser technology to dealer with a many and the Samment works of the Mas An Indium Gallium Arsenide Phosphorus solid-state laser diode emits 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
Image /page/1/Picture/0 description: The image shows the text "K082938" written in a handwritten style, with a line drawn underneath it. Below the line, the word "CONFIDENTIAL" is written in bold, capitalized letters. The text appears to be part of a document or label, possibly indicating a confidential code or reference number.
Page (2) of (2)
INDICATIONS FOR USE:
This device may be used for the following indications:
- Light activation for bleaching materials for teeth whitening
- = Laser-assisted whitening/bleaching of teeth
CONTRAINDICATIONS:
All clinical procedures performed with the ezlase"M 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, which might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disorders, sleep apnea, and immune system deficiency, or any medical conditions or medications that may contraindicate use of certain light/laser type sources associated with this device. Medical clearance from the patient's physician is advisable when doubt exists regarding treatment.
SUBSTANTIAL EQUIVALENCE:
The purpose of this 510(k) is to expand the current exlase™ indications for use (K061898) to include teeth whitening, an indication already cleared by the FDA for equivalent medical devices as part of the following 510(k) submissions: K003385 (Twilite™), K993002, K050824, K072106, (Ceralas D laser systems), and K060114 (Vectra™). Based on this comparison, the ezlase™ is substantially equivalent in relation to previous cleared devices.
CONCLUSION:
The indications requested by this 510/k) are the same as those previously cleared by the FDA for other equivalent devices. Substantial equivalency for the ezlase™ has been determined through comparison to previously cleared devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolase Technology, Inc. % Ms. Ioana M. Rizoiu VP, Clinical R & D 4 Cromwell Irvine, California 92618
DEC 2 2 2008
Re: K082938
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 16, 2008 Received: December 17, 2008
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.
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K
Device (Trade) Name: ezlase™
Indications for Use:
-
Light activation for bleaching materials for teeth whitening
K082938 -
Laser-assisted whitening/bleaching of teeth
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dind Krone la MXM 12/22/2005
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number USQ935