(189 days)
Not Found
No
The description focuses on fixed parameters, automatic calculation based on set parameters, and independent management of outputs, with no mention of learning, adaptation, or complex data analysis characteristic of AI/ML.
Yes
The device is intended to provide topical heating for the temporary relief of pain and stiffness, increase blood circulation, and temporary muscle relaxation, which are therapeutic claims.
No
The device description and intended use clearly state that the Lucia is a therapy device designed to provide topical heating for temporary pain relief and increased circulation, not for diagnosing conditions.
No
The device description explicitly mentions hardware components such as a hand-held treatment probe, drive unit, power supply, controls, and optional treatment probes containing radiating elements. It is not 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 Lucia is for providing topical heating to the body for therapeutic purposes (pain relief, increased blood circulation, muscle relaxation). This involves interacting directly with the patient's body.
- Device Description: The description details a hand-held probe that emits light energy for treatment. This is a physical therapy device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Lucia's function is therapeutic, not diagnostic.
N/A
Intended Use / Indications for Use
The Lucia is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
Product codes
ILY
Device Description
The Lucia has a hand-held treatment probe, is non-invasive, low level visible lamp that provides continuous heat therapy at fixed frequency, The System consists of a Drive Unit, Power Supply, controls and optional treatment probes that contain the visible radiating elements. The Lucia generator automatically calculates energy output in relation to set treatment parameters. The parameters (treatment time, output power delivered) can be adjusted by using key, treatment specifications and menus. The progress of the treatment is displayed on the LCD display in real time. The Lucia generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The Lucia generator is supplied with 2 completely independent outputs for using two treatment probes. The LCD displays operating parameters from both channels. This allows two operators to carry out laser therapy independently: just like having two separate instruments.
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
Performance data was presented which showed that skin temperature was elevated as required for this type of device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
510(k) Summary for the Lucia
FEB 2 5 2011
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92(c).
1. General Information
Submitter:
Meridian Co., Ltd. Poonglim Tech-one Bldg.. 273-10 3F, Seongsu-dong 2 ga, Seongdong-gu Seoul, Korea Tel: 82-2-2103-3300, Fax: 82-2-2103-3333
Chulgyu Lee, R&D Deputy Director Contact Person: laser@meridian.co.kr
Summary Preparation Date: August 19, 2010
2. Names
Lucia Device Trade Name: Common Name: Classification Name:
Infrared lamp Lamp, infrared, therapeutic, heating Product Code: ILY (21 CFR 890.5500) Panel: Physical Medicine
3. Predicate Device
LAPEX BCS (K081962), Meridian Co., Ltd.
4. Device Description
The Lucia has a hand-held treatment probe, is non-invasive, low level visible lamp that provides continuous heat therapy at fixed frequency, The System consists of a Drive Unit, Power Supply, controls and optional treatment probes
1
that contain the visible radiating elements. The Lucia generator automatically calculates energy output in relation to set treatment parameters. The parameters (treatment time, output power delivered) can be adjusted by using key, treatment specifications and menus. The progress of the treatment is displayed on the LCD display in real time. The Lucia generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The Lucia generator is supplied with 2 completely independent outputs for using two freatment probes. The LCD displays operating parameters from both channels. This allows two operators to carry out laser therapy independently: just like having two separate instruments.
5. Indications for Use
The Lucia is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
Substantial Equivalence 6.
The Lucia is substantially equivalent to the LAPEX BCS (K081962) which is also manufactured by Meridian Co., Ltd. The Lucia has the same intended use as and similar technological characteristics as the predicate device. The Lucia utilizes laser diodes to elevate tissue temperature to a range which is recognized to provide temporary relief of certain muscle and joints pains. The technological characteristics of the predicate device are exactly the same as the Lucia. The Lucia described in this 510(k) has the same intended use, indications for use, and technological characteristics as the currently cleared predicate device and is substantially equivalent to the identified predicate device.
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7. Performance Data
. . . . .
Performance data was presented which showed that skin temperature was elevated as required for this type of device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Meridian Co., Ltd. % Research Practice Partners, Inc. Vinod Podichetty, M.D. 3550 SW 148th Avenue, Suite 110 Miramar, Florida 33027
FEB 2 5 201
Re: K102375
Trade/Device Name: Lucia Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: February 18, 2011 -Received: February 22, 2011
Dear Dr. Podichetty:
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
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Page 2 - Vinod Podichetty, M.D.
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 liating (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of morning 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 ellectronic 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/ucm1 1.5809.html 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 1807.97). 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Aty B. R h
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K102375
Device Name: Lucia___
Indications for Use:
The Lucia is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
| Prescription Use X | |
|---|---|
| -------------------- | -- |
AND/OR
| Over The Counter Use | |
|---|---|
| ---------------------- | -- |
| (Part 21 CFR 801 Subpart D) | |
|---|---|
| Subpart C) |
| (Part 21 CFR 801 | |
|---|---|
| ------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Page 1 of 1 |
| Nul Re dl | for m x va | |
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| (Division Sign-Off) | ||
| Division of Surgical, Orthopedic, | ||
| and Restorative Devices |
. 510(k) Number K102375