(49 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is also not available, further limiting the ability to identify such technology.
Yes
The device is indicated to treat a medical condition (moderate inflammatory Acne Vulgaris).
No
The device is indicated to treat, not diagnose, dermatological conditions, specifically moderate inflammatory Acne Vulgaris.
No
The 510(k) summary describes a device with a model number (UBL-417) and a name (Panosol II Tru-Blu) that strongly suggests a physical light therapy device, not software. The description of "treating dermatological indications" and "moderate inflammatory Acne Vulgaris" further points to a hardware-based treatment modality. There is no mention of software as the primary or sole component.
Based on the provided information, the Panosol II Tru-Blu UBL-417 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat dermatological conditions, specifically moderate inflammatory Acne Vulgaris. This is a therapeutic use, not a diagnostic one.
- 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.)
- Providing information about a patient's health status, disease, or condition based on the analysis of these samples.
- Using reagents or kits for testing.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Panosol II Tru-Blu UBL-417 is a light therapy device used for treatment.
N/A
Intended Use / Indications for Use
The Panosol II Tru-Blu UBL-417 is generally indicated to treat dermatological indications. The Panosol II Tru-Blu UBL-417 is specifically indicated to treat moderate inflammatory Acne Vulgaris
Product codes
FTC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and tail feathers flowing downwards. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
National Biological Corporation % Mr. George Kriner Director of Regulatory Affairs 1532 Enterprise Parkway Twinsburg, Ohio 44087
MAY 2 2 2007
Re: K070934
Trade/Device Name: Panosol Tru-Blu Phototherapy System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: March 30, 2007 Received: April 3, 2007
Dear Mr. Kriner:
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.
1
Page 2 - Mr. George Kriner
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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
For
Mark N. Melkerson
Director
me
Dep Director
5/22/07
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name:
Panosol Tru-Blu Phototherapy System
Indications for Use:
The Panosol II Tru-Blu UBL-417 is generally indicated to treat dermatological indications. The Panosol II Tru-Blu UBL-417 is specifically indicated to treat moderate inflammatory Acne Vulgaris
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number