(126 days)
Not Found
No
The summary describes a light therapy device with a vibration function and does not mention any AI or ML capabilities.
Yes
The device is intended for therapeutic purposes such as temporary relief of pain, arthritis, muscle spasm, and to promote relaxation and increased blood circulation.
No
Explanation: The device is intended to deliver heat to provide topical heating for therapeutic purposes such as pain relief, muscle relaxation, and increased blood circulation, not for diagnosing conditions.
No
The device description clearly states it is an "LED panel" and mentions "biocompatible material" and "soothing vibration function," indicating it is a physical hardware device that emits light and vibrates.
Based on the provided information, the OLIZ LTB-1000A is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for delivering heat in the IR spectrum for topical heating and temporary relief of pain, stiffness, muscle spasm, and to increase local blood circulation. This is a therapeutic use, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the device (LED panel, biocompatible material, specific wavelengths of light) and its function (producing light for topical heating and providing vibration). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The OLIZ LTB-1000A is a therapeutic device that uses light and vibration for pain relief and muscle relaxation.
N/A
Intended Use / Indications for Use
The OLIZ LTB-1000A is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of min, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The OLIZ LTB-1000A is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with biocompatible material, which uses specific wavelengths of light. OLIZ LTB-1000A produces light in the near infrared region of the spectrum (850nm) intended to provide topical heating for temporary pain relief. This device provides a soothing vibration function for the purpose of enhancing the user's satisfaction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Contours of the target areas of the anatomy.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Non-Clinical performance test comparing with predicate device: The test results along with the comparison discussion to the predicate device demonstrated that the OLIZ LTB-1000A has met the system requirements. Also, according to the performance test, the device surface temperature is less than 40 ℃. The proposed device presented similar technological specifications to the presented predicate devices and therefore, is substantially equivalent to the predicate devices.
Bench test: Performance testing of the OLIZ LTB-1000A was conducted to verify that the device met all design specifications. The test results demonstrate that the OLIZ LTB-1000A complies with all requirements, including international and FDA-recognized consensus standards: EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-1-11, EN/IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10.
Clinical performance: Not applicable.
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
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2022
LTBIO Co., Ltd. % Jaden Keum Regulatory Affairs Consultant KMC, Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, South Korea 08390
Re: K221189
Trade/Device Name: OLIZ LTB-1000A Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: May 27, 2022 Received: May 31, 2022
Dear Jaden Keum:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221189
Device Name OLIZ LTB-1000A
Indications for Use (Describe)
The OLIZ LTB-1000A is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of min, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
| Type of Use (Select one or both, as applicable) | |||||
|---|---|---|---|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for LTBIO. The logo consists of a colorful, abstract shape on the left, resembling a wave or a stylized leaf, transitioning from orange to blue. To the right of the shape, the text "LTBIO" is written in a bold, sans-serif font, with the letters in a dark blue color. The logo appears to be for a biotechnology or life sciences company.
510(k) SUMMARY - K221189
This summary of 510(k) –safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: August 29, 2022
1. GENERAL INFORMATION
1.1 Submitter Information
- . Submitter Name: LTBIO Co., Ltd.
- . Address
- : 1058, B-dong, Seongnam SKV1 Tower, 14, Galmachi-ro 288beon-gil, Jungwon-
- gu, Seongnam-si, Gyeonggi-do, 13201, Republic of Korea
- . Telephone Number: +82-31-608-1058 . Fax: +82-31-608-1060
1.2 Contact Person
- . Name: Jaden Keum (Consultant / KMC, Inc.)
- Address: Rm. No. 1709, 123, Digital-ro 26-gil, Guro-gu, 08390, Republic of Korea .
- . Telephone Number: +82-70-8965-5554 . Fax: +82-2-2672-0579
- . E-mail: js.keum@kmcerti.com
2. DEVICE INFORMATION
- 2.1 Trade/Device Name: OLIZ LTB-1000A
- 2.2 Regulation Number: 21CFR 890.5500
- 2.3 Device Common Name: Infrared lamp
- 2.4 Regulation Name: Infrared Lamp
- 2.5 Product Code: ILY
- 2.6 Device Class: Class II
- 2.7 Review Panel: Physical Medicine
4
Image /page/4/Picture/0 description: The image shows the logo for "LTBIO". The logo consists of a stylized, abstract shape on the left, resembling a wave or ribbon, with colors transitioning from orange to blue. To the right of the shape, the text "LTBIO" is displayed in a bold, sans-serif font. The "LT" is in blue, matching the blue in the abstract shape, while the "BIO" is in a darker gray or black color.
3. PREDICATE DEVICE
| Manufacturer | BioPhotas |
|---|---|
| Device Name (Trade Name) | Celluma3 |
| 510(k) Number | K152280 |
4. DEVICE DESCRIPTION
The OLIZ LTB-1000A is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with biocompatible material, which uses specific wavelengths of light. OLIZ LTB-1000A produces light in the near infrared region of the spectrum (850nm) intended to provide topical heating for temporary pain relief. This device provides a soothing vibration function for the purpose of enhancing the user's satisfaction.
5. INDICATIONS FOR USE
The OLIZ LTB-1000A is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
| Feature | Proposed Device
LTBIO OLIZ LTB-1000A
K221189 | Predicate Device
BioPhotas Celluma3
K152280 | Analysis of
Technological
Differences |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation No. | 21CFR§890.5500,
Infrared Lamp | 21CFR§890.5500,
Infrared Lamp | Same |
| Product Code | ILY | ILY, OHS, OLP | Same as
predicate device
except for
product codes
OHS and OLP
which are
regarding acne
and wrinkle
features that our
products do not
have. Thus this
difference
doesn't affect
the safety and
effectiveness. |
| Indications for
use | The OLIZ LTB-1000A is
intended to deliver heat in the | The BioPhotas Celluma3 is
intended to deliver heat in | Same as
predicate device |
| Feature | Proposed Device
LTBIO OLIZ LTB-1000A
K221189 | Predicate Device
BioPhotas Celluma3
K152280 | Analysis of
Technological
Differences |
| | IR spectrum to provide
topical heating for the
purpose of elevating tissue
temperature; for the
temporary relief of minor
muscle and joint pain,
arthritis and muscle spasm;
relieving stiffness; promoting
the relaxation of muscle
tissue; and to temporarily
increase local blood
circulation. | the IR spectrum to provide
topical heating for the
purpose of elevating tissue
temperature; for the
temporary relief of minor
muscle and joint pain,
arthritis and muscle spasm;
relieving stiffness;
promoting the relaxation of
muscle tissue; and to
temporarily increase local
blood circulation. The blue
spectrum light is intended to
reduce mild to moderate
inflammatory acne vulgaris.
The Celluma3 is intended to
emit energy in the red and
infrared spectrum for use in
dermatology for the
treatment of periorbital
wrinkles. | except acne
vulgaris and
wrinkles
function. |
| Mechanism of
Action | Use of red light for elevating
tissue temperature and IR
light. | Use of visible blue light in
treatment of acne, red light
for elevating tissue
temperature and IR light in
improving appearance of
periorbital wrinkles. | Same as
predicate device
except acne
vulgaris and
wrinkles
function. |
| Maximum device
surface temperature | Less than 40°C | Not publicly available | - |
| Wavelengths | 655nm, 850nm | 465nm, 640nm, 880nm | Predicate device
includes blue
light for acne
treatment not
available in the
subject device. |
| Electrical power | Use Li-ion batteries
(3.7v_1800mA x2) | 110 - 120 V | This difference
does not affect
the performance
of the product,
and the safety
has been proven
by IEC 60601-1 |
| Treatment | | | |
| | 15 min. Twice a day
(Total 210 min. per week) | 3 times a week for 30 min.
4 weeks
(Total 90 min. per week) | This difference
does not affect
the performance
and safety of the
product when
following the
recommended
usage times. |
| Electrical Safety | IEC 60601-1 & collateral
standards | IEC 60601-1 & collateral
standards | Same |
| Use | OTC | OTC | Same |
5
Image /page/5/Picture/0 description: The image shows the logo for LTBIO. The logo consists of a stylized swoosh in orange and blue, followed by the text "LTBIO" in blue and black. The swoosh is on the left side of the logo, and the text is on the right.
6
Image /page/6/Picture/0 description: The image shows the logo for LTBIO. The logo consists of a stylized swoosh in blue and orange on the left, followed by the text "LTBIO" in blue and black. The "LT" is in blue, while the "BIO" is in black.
7
Image /page/7/Picture/0 description: The image shows the logo for LTBIO. The logo consists of a stylized, abstract shape on the left, resembling a curved wave or ribbon, transitioning from orange to blue. To the right of this shape are the letters "LTBIO" in a combination of blue and black. The "LT" is in blue, while the "BIO" is in black.
7. PERFORMANCE Data
7.1 Non-Clinical performance test comparing with predicate device
The test results along with the comparison discussion to the predicate device demonstrated that the OLIZ LTB-1000A has met the system requirements. Also, according to the performance test, the
device surface temperature is less than 40 ℃. The proposed device presented similar technological specifications to the presented predicate devices and therefore, is substantially equivalent to the predicate devices.
7.2 Bench test
Performance testing of the OLIZ LTB-1000A was conducted to verify that the device met all design specifications. The test results demonstrate that the OLIZ LTB-1000A complies with all requirements, including international and FDA-recognized consensus standards:
EN/IEC 60601-1 (FDA #19-4) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN/IEC 60601-1-2 (FDA #19-8) Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests
EN/IEC 60601-1-11 (FDA #19-14) Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
EN/IEC 62304 (FDA #13-79) Medical device software - Software life cycle processes
ISO 10993-1 (FDA #2-258) Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5 (FDA #2-245) Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 (FDA #2-174) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
7.3 Clinical performance
Not applicable
8. CONCLUSION
Substantial Equivalence:
The indications for use and technological characteristics of the OLIZ LTB-1000A are substantially equivalent to the indications for use and technological characteristics of the predicate device. The design and components in the OLIZ LTB-1000A are similar to predicate Celluma 3. The differences do not negatively affect the safety or efficacy of the device as supported by the results of the performance tests. The performance specifications of the OLIZ LTB-1000A are substantially equivalent to those in the predicate device. The safety features and compliance with safety standards
8
Image /page/8/Picture/0 description: The image shows the logo for LT BIO. The logo consists of a stylized wave-like graphic in shades of orange and blue, followed by the text "LTBIO" in a combination of blue and gray. The "LT" is in blue, while the "BIO" is in gray.
in the OLIZ LTB-1000A are similar to the safety features and compliance with safety standards found in the predicate device. Patient contact materials were partly modified and tested for biocompatibility. Any differences in the technological characteristics do not raise new safety or effectiveness concerns. Consequently, it can be concluded that the OLIZ LTB-1000A is substantially equivalent to the predicate device, cleared under 510(k) K152280.