(156 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology. The device description is not available, but the intended use and lack of other relevant sections strongly suggest it is a traditional phototherapy system.
Yes
The device is described as a "Phototherapy System" intended for the "treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma," which are all medical conditions, indicating a therapeutic purpose.
No
Explanation: The "Intended Use" section states that the device is for "treatment" (UVB phototherapy for various skin conditions), not for diagnosis.
No
The device is described as a "Phototherapy System" and lists predicate devices that are physical phototherapy systems (cabinets, equipment). There is no mention of software as the primary component or the device being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the LH-75 Phototherapy System is used for treatment of various skin conditions (psoriasis, vitiligo, etc.) using UVB phototherapy.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Mechanism of Action: Phototherapy involves exposing the skin directly to light, which is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a therapeutic device used for treating patients, not for diagnosing conditions based on in vitro analysis.
N/A
Intended Use / Indications for Use
The LH-75 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-75 Phototherapy System is intended for use on all skin types (I -VI).
Product codes
FTC
Device Description
Not Found
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K022165, K024020, K090097, K063621, K050695
Reference Device(s)
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
1091568
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510(k) Summary
NOV – 5 2009
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
| Date: | May 27, 2009 |
|---|---|
| Submitter's name: | Lerner Medical Devices, Inc. |
| Submitter's Address: | 1545 Sawtelle Ave. Suite 36 |
| Los Angeles, CA 90025 | |
| Submitter's Telephone: | (310) 914 0091 |
| Submitter's Fax: | (310) 914 0095 |
| Contact Person: | Zafirios F. Gourgouliatos, Ph.D., |
| Chief Science Officer | |
| Management Representative | |
| Device Trade Name: | LH-75 Phototherapy System |
| Device Common Name: | Targeted UVB Phototherapy System |
| Device Classification Name: | Ultraviolet lamp for dermatologic / skin disorders |
| Regulation Number: | 878.4630 |
| Product Code: | FTC |
| Classification: | Device Class II |
| Establishment Reg. Number: | 3006793564 |
| List of Predicate Devices: | TheraLight, Inc. |
| UV1 20-2 UVA / UVB Phototherapy System | |
| K022165, K024020, | |
| Lerner Medical Devices, Inc. | |
| LH-75T Phototherapy System | |
| K090097 | |
| Daavlin Distributing Co. | |
| 3 Series Phototherapy Cabinet | |
| K063621 | |
| Daavlin Distributing Co. | |
| Flex Controlled Phototherapy Equipment | |
| K050695 |
.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV - 5 2009
Lemer Medical Devices, Inc. % Zafirios Gourgouliatos, Ph.D. Chief Science Officer and Management Representative 1545 Sawtelle Boulevard. Suite 36 Los Angeles, California 90025
Re: K091568
Trade/Device Name: LH-75 Phototherapy System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: October 23, 2009 Received: November 02, 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 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
2
Page 2 - Zafirios Gourgouliatos, Ph.D.
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
For
Mark N. Mello
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Device Name: LH-75 Phototherapy System
The LH-75 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-75 Phototherapy System is intended for use on all skin types (I -VI).
X O OR Over-the-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription 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)
MichRP. Ogle frc sxm
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091568