(42 days)
Not Found
No
The summary describes a standard phototherapy system with a light source, console, and handpiece for delivering controlled doses of UV-B light. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies focus on spectral output and technological specifications, not algorithmic performance.
Yes
The device is intended for use in UVB phototherapy for the treatment of various medical conditions such as psoriasis, vitiligo, and atopic dermatitis.
No
The device is a phototherapy system used for treatment, not for diagnosing conditions.
No
The device description explicitly states it consists of a Console, Handpiece, lamp, ballast, electrical cable, and attachments, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treatment of skin conditions using UVB phototherapy. IVDs are used for the diagnosis of diseases or conditions.
- Device Description: The device is a light source and energy delivery system that emits UV-B light. It does not involve the examination of specimens (like blood, urine, or tissue) outside of the body, which is a key characteristic of IVDs.
- Lack of IVD-related information: The description does not mention any reagents, assays, or analysis of biological samples, which are typical components of IVD devices.
This device is a therapeutic device, specifically a phototherapy system.
N/A
Intended Use / Indications for Use
The LH-75T Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The LH-75T Phototherapy System is intended for use on all skin types (I -VI).
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
The LH-75T Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 mm) light for use in phototherapy and allows delivery of controlled doses!
The LH-75T consists of a Console that contains the electronics and a Handpiece that contains the lamp and the ballast. The console and handpiece are connected with an electrical cable. A Spot Treatment Attachment (LP-3) jand a Fiber-optic Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Attachment (LB-10) are connected to the handpiece for selective treatment of skin lesions without exposure of adjacent, healthy tissues. The desired dose is selected using controls on the panel of the console and activated with either a switch on the panel or foot-switch. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
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
by or under the direction of a physician
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 data have been submitted as part of the 510(k) application to confirm that the spectral output of the LH-75T Phototherapy System is between 290 and 320 nm, which is similar to spectra emitted by predicate devices. Other performance data included in the application show that the technological specifications are similar to those of the predicate devices.
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.
K022165, K024020, K040062, K073587
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
FEB 2 6 2009
Page ① of ③
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
Date:
Submitter's name:
Submitter's Address:
Submitter's Telephone:
Submitter's Fax:
Contact Person:
Device Trade Name:
Device Common Name:
Device Classification Name:
Regulation Number:
Product Code:
Classification:
Establishment Reg. Number:
List of Predicate Devices:
January 14, 2009
Lerner Medical Devices, Inc.
1545 Sawtelle Ave. Suite 36 Los Angeles, CA 90025
(310) 914 0091
(310) 914 0095
Zafirios F. Gourgouliatos, Ph.D., Chief Science Officer Management Representative
LH-75T Phototherapy System
Targeted UVB Phototherapy System
Ultraviolet lamp for dermatologic / skin disorders
878.4630
FTC
Device Class II
3006793564
TheraLight, Inc. UV1 20-2 UVA / UVB Phototherapy System K022165, K024020,
Lerner Medical Devices, Inc. Levia Phototherapy System K040062
Daavlin Distributing Co. Dermapal with Digital Timer K073587
1
ge ② of ③
Device Description:
The LH-75T Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 mm) light for use in phototherapy and allows delivery of controlled doses!
The LH-75T consists of a Console that contains the electronics and a Handpiece that contains the lamp and the ballast. The console and handpiece are connected with an electrical cable. A Spot Treatment Attachment (LP-3) jand a Fiber-optic Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Attachment (LB-10) are connected to the handpiece for selective treatment of skin lesions without exposure of adjacent, healthy tissues. The desired dose is selected using controls on the panel of the console and activated with either a switch on the panel or foot-switch. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
Indications for Use:
The LH-75T Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The LH-75T Phototherapy System is intended for use on all skin types (I -VI).
Substantial Equivalence:
The LH-75T Phototherapy System emits UVB light within the spectral band of 290 -320 nm, similar to that of all the predicate devices. This light has been shown to be safe and effective in the treatment of scalp psoriasis. The difference between the LH-75T Phototherapy System and the predicate devices is the configuration of the hardware >>>
The delivery components (Spot Treatment Attachment LP-3, Fiber-optic Brush Attachment LB-10) and control electronics are identical to those of the Levia Phototherapy System (Lerner Medical Devices, Inc., K040062).
The lamp is situated the Handpiece and is connected to the console with an electrical cable in a manner similar to the Dermapal with Digital Timer predicate device. (Daavlin Distributing Co., K073587).
The LH-75T Phototherapy System has a Power Meter embodied in the console to facilitate calibration, in a manner similar to the UV1 20-2 UVA / UVB Phototherapy System (TheraLight, Inc., K022165, and K024020). The Power Meter is used to indicate output of the LH-75T for operator convenience. The meter is similar to the meter of the Levia Phototherapy System.
Lemer Medical Devices. Inc. believes that these similarities provide added convenience to the user and do not raise new questions about safety or effectiveness.
2
090097 Page (3) of (3)
Performance Data:
Performance data have been submitted as part of the 510(k) application to confirm that the spectral output of the LH-75T Phototherapy System is between 290 and 320 nm, which is similar to spectra emitted by predicate devices. Other performance data included in the application show that the technological specifications are similar to those of the predicate devices.
Conclusion:
On the basis of the information provided in this summary, Lerner Medical Devices, Inc. believes the LH-75T Phototherapy System is substantially equivalent to 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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lerner Medical Devices, Inc. % Zafirios Gourgouliatos, Ph.D 1545 Sawtelle Boulevard, Suite 36 Los Angeles, California 90025
Re: K090097
FEB 2 6 2009
Trade/Device Name: LH-75T Phototherapy System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: January 14, 2009 Received: January 15, 2009
Dear Dr. Gourgouliatos:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Zafirios Gourgouliatos, Ph.D
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
y/m. D. fr
Mark N. Melkerson Director . Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number_K090097
Device Name: LH-75T Phototherapy System
The LH-75T Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The LH-75T Phototherapy System is intended for use on all skin types (I -VI).
Prescription Use X OR Over-the-Counter Use (per 21 CFR 801.109)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Milke Ryl for mtn
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K090097