(43 days)
Not Found
No
The description focuses on microprocessor control for light delivery and does not mention any AI/ML capabilities for diagnosis, treatment planning, or other functions. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for the treatment of various skin conditions like psoriasis, vitiligo, atopic dermatitis, seborrheic dermatitis, and leukoderma, which are medical treatments.
No
The device is described as a phototherapy system used for treatment, delivering UV light to a localized area of skin. It does not mention any function for diagnosing conditions.
No
The device description explicitly states it is a "microprocessorcontrolled, high-intensity ultraviolet light source" and includes hardware components like a Lightguide and Handpiece for delivering UV light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The TheraLight UV120-2 UVA / UVB Phototherapy System is a device that delivers light therapy directly to the skin for the treatment of specific skin conditions. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it is for "PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis." This is a therapeutic application, not a diagnostic one.
Therefore, the TheraLight UV120-2 UVA / UVB Phototherapy System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TheraLight UV120-2 UVA / UVB Phototherapy System is intended for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.
Product codes
FTC
Device Description
The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¾" square patch of skin without exposure to neighboring, healthy tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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)
System performance data (UVB output spectra) is the same or very similar that for the claimed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
024020
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JAN 1 7 2003
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
| Submitter's name: | TheraLight, Inc. |
|---|---|
| Submitter's Address: | 2794 Loker Avenue West, Suite 105 |
| Carlsbad, CA 92008-6616 | |
| Telephone: | (760) 930-8000 |
| Contact: | Kevin E. Daly |
| Date Prepared: | December 2, 2002 |
| Device Trade Name: | UV120-2 UVA / UVB Phototherapy System |
| Device Common Name: | Targeted UVA / UVB Phototherapy System |
| Device Classification Name: | Ultraviolet lamp for dermatologic / skin |
| disorders (ref. 21 CFR 878.4630) | |
| Predicate Devices: | TheraLight, Inc. |
| UV120-2 UVA / UVB Phototherapy System | |
| K022165 | |
| Lumenis, Ltd. | |
| BClear UVB Phototherapy System | |
| K020591 | |
| PhotoMedex, Inc. | |
| XTRAC Excimer Laser Phototherapy System |
,
1
2/2
Device Description:
The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¾" square patch of skin without exposure to neighboring, healthy tissues.
Intended Use:
The TheraLight UV120-2 UVA / UVB Phototherapy System is intended for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.
Performance Data:
The TheraLight UV120-2 UVA / UVB Phototherapy System currently is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema) and seborrheic dermatitis. System performance data (UVB output spectra) is the same or very similar that for the claimed predicate devices.
Conclusion:
On the basis of the information provided in this Summary, TheraLight, Inc. believes the UV120-2 UVA / UVB Phototherapy System is substantially equivalent to legally commercialized predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2003
Theralight, Inc. Kevin E. Daly Chief Operating Officer 2794 Loker Avenue West, Suite 105 Carlsbad, California 92008-6616
Re: K024020
Trade/Device Name: UV120-2 UVA/UVB Phototherapy System Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatologic/skin disorders Regulatory Class: Class II Product Code: FTC Dated: December 3, 2002 Received: December 5, 2002
Dear Mr. Daly:
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
3
Page 2 -- Mr. Kevin E. Daly
(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. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page | of |
510(k) Number (if known): 上のスイリ20
Device Name: TheraLight UV120-2 UVA/UVB Phototherapy System
Indications for Use:
The TheraLight UV120-2 UVA / UVB Phototherapy System is indicated for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Optional Format 3-10-98)
ivision Sign-Off Jivision of General, Restorative and Neurological Devices