(504 days)
Not Found
No
The device description focuses on light emission and a timed treatment cycle, with no mention of AI, ML, or image processing. Performance studies are related to safety and biocompatibility, not algorithmic performance.
Yes
The device is described as a "Phototherapy System for Acne" that provides "phototherapeutic blue light to treat mild to moderate inflammatory acne," which directly indicates a therapeutic purpose.
No
The description states the device "provides phototherapeutic blue light to treat mild to moderate inflammatory acne," indicating a therapeutic rather than diagnostic function. It does not mention any capabilities for identifying, evaluating, or monitoring a disease state.
No
The device description explicitly states it is a "hand held light device" and mentions "light modules are contained in the changeable head of a hand held device," indicating it is a physical hardware device that emits light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat mild to moderate inflammatory acne" using phototherapy (light). This is a therapeutic treatment applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "hand held light device" that emits blue light. This aligns with a therapeutic device, not a device used to analyze biological samples.
- 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 information for diagnosis, monitoring, or screening
Therefore, the ClearWave Phototherapy System for Acne is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ClearWave Phototherapy System for Acne is designed for Over-the-Counter use. Clear Wave® provides phototherapeutic light for the treatment of dermatological conditions in the convenience of a consumer's home. The target population for the Clear Wave® Phototherapy System for Acne is that for the predicate device, Tanda Skincare System.
The ClearWave Phototherapy System for Acne provides phototherapeutic blue light to treat mild to moderate inflammatory acne.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONE
Device Description
The Clear Wave® Phototherapy System for Acne is a hand held light device which emits a low intensity of blue light at a wavelength of 414 ± 10 nm in the visible range of the spectrum. The head is programmed with a timed treatment cycle. The light modules are contained in the changeable head of a hand held device. The Clear Wave® Phototherapy System for Acne is small and light weight which allows for easy handling and mobility.
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
Over-the-Counter use. In the convenience of a consumer's home.
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)
Performance Testing: The ClearWave® Phototherapy System for Acne complies with UL 60601-1 (Medical Electrical Equipment: Particular requirements for basic safety) and EN 60601-1-2 (Electromagnetic Compatibility). Analysis of the material has demonstrated compliance to ISO 10993 (Biocompatibility). Usability testing has show suitability for OTC-labeling. Spectral testing and other verification/validation testing confirmed performance of hardware and software to requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
SEP 3 2010
Submitter
Verilux 340 Mad River Park, Ste 1 Waitsfield, VT 05673 1-886-544-4865
Contact
Ryan Douglas MFG Solutions 1259 Willow Lake Blvd St. Paul, MN 55075 Phone: 651-203-2100: Fax: 651-203-2110
Submission Date: April 15, 2009
Trade Name: ClearWave® Phototherapy System for Acne (CWST2)
Common Name: ClearWave® Phototherapy System
Classification Name: Laser surgical instrument for use in plastic surgery and Dermatology
Classification Panel: General and Plastic Surgery (21 CFR 878.4810, Product Code GEX, Panel 79)
Substantial Equivalence:
The ClearWave® Phototherapy System for Acne is substantially equivalent to the Tanda Skincare System (K080591). The intended use and technological characteristics of the Clear Wave® Phototherapy System for Acne are similar to the intended use and technological characteristics of the listed predicate device. Differences between the Clear Wave® Phototherapy System for Acne and the predicate device do not introduce new risks.
Device Description:
The Clear Wave® Phototherapy System for Acne is a hand held light device which emits a low intensity of blue light at a wavelength of 414 ± 10 nm in the visible range of the spectrum. The head is programmed with a timed treatment cycle. The light modules are contained in the changeable head of a hand held device. The Clear Wave® Phototherapy System for Acne is small and light weight which allows for easy handling and mobility.
Intended Use:
The Clear Wave® Phototherapy System for Acne is designed for Over-the-Counter use. Clear Wave® provides phototherapeutic light for the treatment of dermatological conditions in the convenience of a consumer's home. The target population for the Clear Wave® Phototherapy System for Acne is that for the predicate device, Tanda Skincare System.
Indication for Use:
The ClearWave Phototherapy System for Acne provides phototherapeutic blue light to treat mild to moderate inflammatory acne.
Technological Characteristics
Data obtained through spectral testing indicates that the irradiance of the ClearWave® Phototherapy System for Acne at a practicable distance from the skin surface (3.5mm) is comparable with the cited predicate device. The technology, mode of operation, and general principles for treatment with this device are the predicate device.
Performance Testing
The ClearWave® Phototherapy System for Acne complies with UL 60601-1 (Medical Electrical Equipment: Particular requirements for basic safety) and EN 60601-1-2 (Electromagnetic Compatibility). Analysis of the material has demonstrated compliance to ISO 10993 (Biocompatibility). Usability testing has show suitability for OTC-labeling. Spectral testing and other verification/validation testing confirmed performance of hardware and software to requirements.
510(k) Submission Confidential
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
3 2010
SEP
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Verilux % MFG Solutions, Inc. Mr. Ryan Douglas 1259 Willow Lake Boulevard St. Paul, Minnesota 55110
Re: K091125
Trade/Device Name: ClearWave Phototherapy System for Acne 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: ONE Dated: August 24, 2010 Received: August 26, 2010
Dear Mr. Douglas:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
2
Page 2 - Mr. Ryan Douglas
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 (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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerso Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
SEP 3 2010
1091125
510(k) Number (if known): ko9 11 25
、・
Device Name: _________________________________________________________________________________________________________________________________________________________________ ClearWave Phototherapy System for Acne
The ClearWave Phototherapy System for Acne provides phototherapeutic blue light to treat mild to moderate inflammatory acne.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use x (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P.P. R
(Division Sign-Off) (Division Sign-QT)
Division of Surgical, Orthopedic, Divises of Restorative Devices
091128
510(k) Number