The LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

THE LIGHTWAVE Deluxe Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

THE LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

THE LIGHTWAVE Deluxe Infrared Light is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Device Description

The LIGHTWAVE™ Professional Deluxe System uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. This technology is commonly referred to as Photobiostimulation, Light Emitting Diode Therapy (LEDT), LLLT, or LED's. The application of LED's to tissue is non-invasive. These devices are solid state and hand free mounted for placement directly over the skin where the treatment is to occur.

The LIGHTWAVE Professional Deluxe LED system is a combination of two sources of high chromatic accuracy. They provide uniform even coverage exposure area. The output wavelengths of LIGHTWAVE Professional Deluxe Range from 630 nm (visible red) to 830nm (near infrared). The LIGHTWAVE Professional Deluxe base unit contains the power supplies and the control unit. The LED panel can be configured to contain one (1), two (2) or three (3) row(s) of LED (600, 1200 or 1800 LEDs respectively) based on system configuration. The LED panel is attached to the end of the arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.

AI/ML Overview

Here's an analysis of the provided text regarding the LIGHTWAVE Professional Deluxe device.

Important Note: The provided document is a 510(k) summary for a medical device. It explicitly states that formal clinical trials were not deemed necessary because the device uses the same technology and intended use as predicate devices. Therefore, the information you requested about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, etc., is largely not present in this document. The "proof" here is based on substantial equivalence to existing devices.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence: The device's intended use and major performance parameters are similar or equivalent to predicate devices (Photo Therapeutics Ltd. K030883, Omnilux Revive (K030426), Omnilux Plus (K043317), Omnilux Revive and Plus Combination (K050216)).	The LIGHTWAVE Professional Deluxe has an "intended use and major performance parameters (energy transmission levels and wavelength)" that are deemed "similar or equivalent to the same characteristics of the Photo Therapeutics Omnilux devices." The output wavelengths range from 630 nm (visible red) to 830nm (near infrared).
Safety and Effectiveness: Demonstrated through compliance with recognized standards.	Testing conducted in accordance with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for safety) and IEC 60601-1-2:2001 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests).
Indicated Uses: The device must meet the performance for its specified indications.	- Red light: Indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions. - Red and Blue light combination: Intended to emit energy in the red and blue region to treat mild to moderate acne vulgaris. - Blue light: Indicated to treat moderate inflammatory acne vulgaris. - Red and Infra-red light combination: Intended to emit energy in the red and infra-red region for the treatment of periorbital wrinkles. - Infrared Light: Intended to emit energy in the IR spectrum to provide topical heating for temporary relief of minor muscle/joint pain, arthritis, muscle spasm; relieving stiffness; promoting muscle relaxation; and temporarily increasing local blood circulation.

Study Details (Based on the provided document)

Since formal clinical trials for this specific device were not conducted, much of the requested information regarding study specifics is not applicable. The primary "study" supporting its market clearance is the comparison to predicate devices and compliance with safety standards.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No clinical test set (patient data) was used for performance evaluation of this specific device. Performance was established by comparison to predicate devices.
- Data Provenance: Not applicable. No patient data from a specific country or retrospective/prospective study was used for this device's performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth based on expert review of a test set was established for this device's performance given the lack of clinical trials. The FDA review process itself involves experts within the agency assessing substantial equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication was used.
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 light therapy system, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-only device. Its performance is related to its physical properties (wavelengths, energy output) and its intended therapeutic effects when applied by a human operator.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the safety and effectiveness claim of this device is primarily substantial equivalence to legally marketed predicate devices whose safety and effectiveness for similar indications have already been established, coupled with compliance with recognized electrical and medical device safety standards (IEC 60601-1 and IEC 60601-1-2:2001). There is no "ground truth" derived from patient-specific data for this device.
The sample size for the training set:
- Not applicable. No training set was used as this device does not involve machine learning or AI algorithms in its performance evaluation.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary

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JAN - 4 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is: _______________________________________________________________________________________________________________________________________________

1. General Information

Contact Person:

Submitter:

K082586

LIGHTWAVE Technologies LLC 2222 W. Parkside Lane Suite 111 Phoenix, AZ 85027 United States

Mike Poling President LIGHTWAVE Technologies LLC 2222 W. Parkside Lane Suite 111 Phoenix, AZ 85027 United States

Summary Preparation Date:

August 21, 2008

Names

Device Name:

Common Name:

Requlation: Product Code: LIGHTWAVE Professional Deluxe

laser instrument, surgical powered, infrared lamp 878.4810, 890.5500 GEX, ILY

3. Predicate Devices

Photo Therapeutics Ltd. K030883, Omnilux Revive (K030426), Omnilux Plus (K043317), Omnilux Revive and Plus Combination (K050216).

4. Device Description

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These devices are solid state and hand free mounted for placement directly over the skin where the treatment is to occur.

5. Indications for use

The LIGHTWAVE Deluxe Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

THE LIGHTWAVE Deluxe Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

THE LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

6. Performance Data

Based upon an analysis of the overall performance characteristics for the device. LIGHTWAVE Technology believes that no significant differences

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exist between the LIGHTWAVE Professional Deluxe and the predicate devices listed above made by Photo Therapeutics.

7. Comparison to Predicate Devices:

The intended use and major performance parameters (energy transmission levels and wavelength) of the LIGHTWAVE Professional Deluxe are similar or equivalent to the same characteristics of the Photo Therapeutics Omnilux devices.

8. Testing

Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as the predicate devices.

Testing information demonstrating safety and effectiveness of the LIGHTWAVE Professional Deluxe in the intended environment of use is supported by testing that was conducted in accordance with the following standards: IEC 60601-1 and IEC 60601-1-2:2001.

10. Conclusions

Based upon an analysis of the overall characteristics for the device in comparison to the predicates, LIGHTWAVE Technologies concludes that the LIGHTWAVE Professional Deluxe is substantially equivalent.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling the perimeter, with the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JAN - 4 2010

LIGHTWAVE Technologies L.L.C. % MDI Consultant, Inc. Ms. Maria F. Griffin 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K082586

Trade/Device Name: Lightwave Professional Deluxe Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II

Product Code: GEX Dated: November 20, 2009 Received: November 23, 2009

Dear Ms. Griffin:

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 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

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Page 2 - Ms. Maria F. Griffin

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millican

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit # 3

Indications for Use

Page 1

510(k) Number (if known): _KO8258 b

Device Name: Lightwave Professional Deluxe

Indications For Use:

The LIGHTWAVE Deluxe Red light is indicated for use in dermatology for treatment of superficial; benign vascular, and pigmented lesions.

THE LIGHTWAVE Deluxe Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

THE LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Prescription Use X (Per 21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device

Devide Evaluation (ODE)

(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K08

Regulation Number and Section

§ 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.