(16 days)
Not Found
No
The summary describes a light therapy device with specific wavelength and irradiance parameters. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is indicated for "specific ultraviolet radiation therapy for diagnosed skin disorders," which describes a therapeutic use for treating medical conditions. Additionally, the device's summary of performance includes "nominal skin irradiance," indicating it delivers energy to the skin for treatment.
No
The device is described as an illumination source for therapy for diagnosed skin disorders, not for diagnosing them.
No
The device description explicitly states it is an "illumination source" that emits UVA radiation, indicating it is a hardware device.
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 health issues.
- Device Function: The VersaClear™ Skin Therapy System UVA (350mm) Light Module is a light source that emits UVA radiation for the treatment of diagnosed skin disorders. It directly interacts with the patient's skin for therapeutic purposes.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples taken from the patient. Its function is to deliver light therapy to the skin.
Therefore, this device falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VersaClear™ Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
The VersaClear™ Skin Therapy System UVA (350mm) Light Module is a 120/240V 50/60 Hz AC illumination source that emits UVA radiation with a peak at 350mm ± S mm.
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 VersaClear™ Skin Therapy System UVA (350nm) Light Module emits UVA radiation at a peak of 350mm +5mm and a bandwidth (Full Width at Half Maximum) of 40nm, and a nominal skin irradiance of from 10-35 mW/cm2.
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
§ 878.4630 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
MAY 2 5 2006
Attachment 4
Page 1 of 1
6/295
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 | |
| Telephone: | (760) 930-8000 |
| Contact: | Kevin E. Daly |
| Chief Operating Officer | |
| Date Prepared: | May 13, 2006 |
| Device Trade Name: | VersaClear™ Skin Therapy System UVA (350nm) |
| Light Module | |
| Device Common Name: | VersaClear™ Skin Therapy System UVA (350nm) |
| Light Module | |
| Device Classification Name: | Ultraviolet lamp for dermatologic / skin disorders |
| (ref. 21 CFR 878.4630). | |
| Predicate Devices: | Flex Controlled Phototherapy Equipment |
| Daavlin Distributing Company | |
| K050695 |
Device Description:
The VersaClear™ Skin Therapy System UVA (350mm) Light Module is a 120/240V 50/60 Hz AC illumination source that emits UVA radiation with a peak at 350mm ± S mm.
Intended Use and Indications for Use:
The VersaClear™ Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
Performance Data:
The VersaClear™ Skin Therapy System UVA (350nm) Light Module emits UVA radiation at a peak of 350mm +5mm and a bandwidth (Full Width at Half Maximum) of 40nm, and a nominal skin irradiance of from 10-35 mW/cm2.
Conclusion:
The VersaClear Skin Therapy System is substantially equivalent to legally commercialized UV phototherapy devices. Comments of
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
TheraLight, Inc. % Mr. Kevin E. Daly Chief Operating Officer 2794 Loker Avenue West, Suite 105 Carlsbad, California 92010
Re: K061295
K001295
Trade/Device Name: VersaClear™ Skin Therapy UVA (350nm) Light Module Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: May 8, 2006 Received: May 9, 2006
Dear Mr. Daly:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 conninered pror to Thay 20, 1978, in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, maniev of the Act include requirements for annual registration, listing of general controls proficturing 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can may be subject to back adden accept 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 that I Dr head statutes and regulations administered by other Federal agencies. You must or any I 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
2
Page 2 - Mr. Kevin E. Daly
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (if known): K061295
Device Name: VersaClear™ Skin Therapy System UVA (350nm) Light Module
Indications for Use:
The VersaClear Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
ﻢ .
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
H, Office of Device Evaluation (ODE) Concurrence of
el.mell
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
Page 1 of 1
KOGI 295 510(k) Numbe