(483 days)
Not Found
No
The device description focuses on LED technology and light wavelengths, with no mention of AI or ML for image processing, data analysis, or treatment optimization. The performance studies rely on equivalence to predicate devices using the same technology.
Yes
The device is indicated for conditions such as mild to moderate acne vulgaris, superficial benign vascular and pigmented lesions, periorbital wrinkles, minor muscle and joint pain, and arthritis, all of which are medical conditions that require treatment. Therefore, the device is a therapeutic device.
No.
The device description and intended use indicate that it is a light therapy device used for treatment of various dermatological conditions and for pain relief through topical heating. There is no mention of it being used to analyze or identify a condition.
No
The device description clearly details hardware components such as LEDs, a base unit containing power supplies and a control unit, an LCD, keyboard, and an LED panel with varying numbers of LEDs. While it mentions user interface software, the core functionality and therapeutic action are based on the hardware emitting light.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The LIGHTWAVE Deluxe Red light system uses light energy applied directly to the skin for therapeutic purposes (treating skin conditions, pain relief, etc.). It does not analyze any biological samples taken from the body.
- Intended Use: The intended uses described are all related to treating conditions on the skin surface or providing topical heating, not analyzing biological specimens.
Therefore, based on the provided information, the LIGHTWAVE Deluxe Red light system is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
GEX, ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
K030883, K030426, K043317, K050216
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
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:
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
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.
1
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.
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 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.
6. Performance Data
Based upon an analysis of the overall performance characteristics for the device. LIGHTWAVE Technology believes that no significant differences
2
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.
3
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
4
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,
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
5
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 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.
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)
OR
Concurrence of CDRH, Office of Device
Devide Evaluation (ODE)
(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K08