(71 days)
Not Found
No
The description focuses on a phototherapy device with a digital timer or microprocessor controller, and there is no mention of AI, ML, or related concepts in the provided text.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders" and is "indicated for the treatment of mild to moderate acne vulgaris."
No
This device is described as a "therapeutic product" designed for treatment, not for diagnosis. Its function is to emit light for therapeutic purposes, such as treating skin disorders and acne.
No
The device description clearly outlines hardware components such as a phototherapy panel, ultraviolet light source, integrated digital timer, microprocessor controller, LCD, and membrane with buttons, indicating it is a physical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders" and "indicated for the treatment of mild to moderate acne vulgaris." This describes a treatment device, not a device used to diagnose a condition by examining samples from the body.
- Device Description: The description focuses on the light source, control panel, and the emission of ultraviolet or blue light for therapeutic purposes. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical components or processes associated with IVDs, such as reagents, assays, sample collection, or analysis of biological markers.
Therefore, this device falls under the category of a therapeutic medical device, specifically a phototherapy unit.
N/A
Intended Use / Indications for Use
The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet or blue light radiation for diagnosed skin disorders.
The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders. The 1-Series, equipped with PL-L36W /03 blue lamps, is indicated for the treatment of mild to moderate acne vulgaris
Product codes
FTC
Device Description
The 1 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light or blue light. The spectral output peaks at wavelengths of 305nm,311nm,350nm,365nm, or 420nm depending on lamp. The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders or blue light radiation for acne vulgaris.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The 1 Series Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate devices. The UV or blue light lamps and cabinet construction used in the production of the predicate devices and the 1 Series Phototherapy Unit are similar.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073587, K050695, K070934, K031805
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
APR 2 8 2010
The Daavlin Distributing Company Submitter's Name:
Registration Number: 1526255
Address:
POSSESS
205 West Bement Street Bryan, Ohio 43506
419.636.6304
Michele Thiel
Telephone:
late
Contact:
Date Prepared: February 3, 2010
Device Trade Name: 1 Series Phototherapy Unit
1 Series Partial- Body Phototherapy Unit Device Common Name:
Device Classification: Class II
ം Product Code: FTC
Regulation Number: CFR 878.4630
Regulation Name: Ultraviolet lamp for dermatologic/skin disorders
1
60037y
Predicate Device: Daavlin Distributing Company Digital DermaPal® K073587
Daavlin Distributing Company Flex Controlled Phototherapy Equipment K050695
National Biological Corporation Panosol Tru-Blu Phototherapy System · K070934
DUSA Pharmaceuticals, Inc. BLU-U, MODEL 4170 K031805
2
100378
Device Description:
The 1 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light or blue light. The spectral output peaks at wavelengths of 305nm,311nm,350nm,365nm, or 420nm depending on lamp. The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders or blue light radiation for acne vulgaris.
Predicate Device Comparison:
The 1 Series Unit is constructed in the same design configuration as the predicate device, utilizing identical energy sources (UV or blue light lamps ) and materials of identical composition. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principals of the 1 Series light emitting medical device are the same or similar to those of the predicate devices.
Intended Use:
The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet or blue light radiation for diagnosed skin disorders.
Performance Data:
The 1 Series Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate devices. The UV or blue light lamps and cabinet construction used in the production of the predicate devices and the 1 Series Phototherapy Unit are similar.
Conclusion:
On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the 1 Series Phototherapy Unit is substantially equivalent to the legally commercialized predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a common symbol associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
The Daavlin Distributing Company % Ms. Michele Thiel 205 West Bement Street Bryan, Ohio 43506
APR 2 8 2010
Re: K100378
Trade/Device Name: 1 Series Phototherapy Unit Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: April 22, 2010 Received: April 22, 2010
Dear Ms. Thiel:
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.
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
4
Page 2 - Ms. Michele Thiel
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
signature
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the word "Daavlin" in a stylized font. The first letter, "D", is larger and bolder than the rest of the letters. The remaining letters are in a smaller, thinner font, and are connected to each other.
Indication for Us
Ki00378 510(k) Number
1 Series Phototherapy Unit Device Name
Indications for Use
The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders. The 1-Series, equipped with PL-L36W /03 blue lamps, is indicated for the treatment of mild to moderate acne vulgaris
Prescription Use X
OR
Over-the-Counter Use
(Please do not write below this line – Continue on another page if needed)
(per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden for him
Division Sign Off
(Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100378