The ezlase™ diode system emits energy in the near- infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Device Description

The ezlase™ diode laser system, was cleared for dental soft tissue indications under KQ61898 and K083069. The system uses a Gallium Aluminum Arsenide (GaAlA) and/or an Indium Gallium Arsenide Phosphorus (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiberoptic cable to a handpiece that emits the energy to the targeted site. A visible light is emitted at the same time to visually identify the treatment location.

AI/ML Overview

This document, K083595, describes a Special 510(k) Summary Statement for the Biolase Technology, Inc. ezlase™ diode laser system. The purpose of this 510(k) is to expand the current indications for use to include therapeutic indications.

Acceptance Criteria and Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative performance metric table as might be found for a diagnostic device. Instead, the justification for the expanded indications relies on substantial equivalence to already cleared predicate devices. The "performance" being demonstrated is that the ezlase™ meets the same therapeutic claims as these predicates.

Acceptance Criteria (Implied)	Reported Device Performance
Device emits energy in the near-infrared spectrum to provide topical heating.	The ezlase™ diode system emits energy in the near-infrared spectrum to provide topical heating.
Device is for temporary relief of minor muscle and joint pain and stiffness.	Confirmed for temporary relief of minor muscle and joint pain and stiffness.
Device is for temporary relief of minor arthritis pain.	Confirmed for temporary relief of minor arthritis pain.
Device is for temporary relief of muscle spasm.	Confirmed for temporary relief of muscle spasm.
Device is for temporary relief of minor sprains and strains.	Confirmed for temporary relief of minor sprains and strains.
Device is for temporary relief of minor muscular back pain.	Confirmed for temporary relief of minor muscular back pain.
Device provides temporary increase in local blood circulation.	Confirmed for temporary increase in local blood circulation.
Device provides temporary relaxation of muscle.	Confirmed for temporary relaxation of muscle.
Equivalence to cleared predicate devices for therapeutic indications.	Determined substantially equivalent to K070516 (Powerlaser), K070024 (Thor VR Single Diode Laser Treatment), K080318 (Alma Laser NIR Module), and K082707 (MedX LPT200 and LPS200).

Study Details:

This submission is a Special 510(k) for expanding indications based on substantial equivalence to existing cleared devices, not a clinical trial demonstrating novel performance against new, specific acceptance criteria through a newly conducted study. Therefore, many of the typical elements of a standalone clinical study are not applicable or explicitly provided in this document.

Sample size used for the test set and the data provenance: Not applicable. This submission doesn't describe a new clinical test set. The basis for approval is substantial equivalence to previously cleared devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no new clinical test set described in this document. The "ground truth" for the predicate devices would have been established during their respective clearances, but details are not provided here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system for therapeutic use, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. The "performance" assessment is based on the functional and claims equivalence to predicate devices, not a standalone algorithm's performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the purpose of this 510(k) submission, the "ground truth" or evidence of effectiveness for the therapeutic indications is derived from the prior FDA clearance of the predicate devices with identical (or very similar) Indications for Use. This implicitly relies on the data and "ground truth" (likely clinical study outcomes or established physiological effects) that supported the original clearances of those predicate devices.
The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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CONFIDENTIAL

Page ① of ②

Date Prepared:

Company:

Contact:

083595

Biolase Technology, Inc. Special 510(k) Summary Statement ezlase™ Therapeutic Indications for Use

510(k) Summary (As required by 21CFR807.92)

December 4, 2008

APR 1 4 2009

Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618 Tel: (949) 361-1200 Fax: (949) 273-6680

Ms. Ioana M. Rizoiu VP, Clinical R&D Tel: (949) 226-8144 email: irizoiu@biolase.com

ezlase™m Trade Name:

Common Name:

Classification Name:

Diode Laser

Infrared Lamp (21CFR §890.5500

ILY

Product Code:

Predicate Devices:

Powerlaser PowerMedic ApS,

Thor VR Single Diode Laser Treatment Thor International Ltd.

MedX LPT 200 Tethered Laser & MedX LPS 200 Portable Laser MedXElectronics, Inc.

DEVICE DESCRIPTION:

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CONFIDENTIAL page (2) of (2)

INDICATIONS FOR USE:

The ezlase diode system emits energy in the near- infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain: the temporary increase in local blood circulation; the temporary relaxation of muscle.

CONTRAINDICATIONS:

All clinical procedures performed with the 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 pattent'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 disease, malignancies, bleeding 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 ezlase™ indications for use (K061898, K083069) to include therapeutic indications. The requested indications have already been cleared by the FDA for several equivalent medical devices, including the following: K070516 (Powerlaser), K070024 (Thor VR Single Diode Laser Treatment), K080318 (Alma Laser NIR Module) and K082707 (MedX LPT200 and LPS200). Based on this comparison, the ezlase™ is substantially equivalent in relation to previously 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR ] 4 2009

Biolase Technology, Inc. % Ms. Ioana Rizoiu VP. Clinical R&D 4 Cromwell Irvine, California 92618

Re: K083595

Trade/Device Name: ezlase™ Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: March 20, 2009 Received: March 24, 2009

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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 - Ms. Ioana Rizoiu

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 A. Millhuser

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K_083595

Device (Trade) Name: ezlase™

Indications for Use:

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)

Neil R. Ogle - Gormsen

(Division Sign-Off) Division of General, Restorative, and Neurological Devices :

510(k) Number K083595

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.