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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OLIZ LTB-1000A, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance is based on the device being "substantially equivalent" to a predicate device (BioPhotas Celluma3 K152280). Therefore, the acceptance criteria are implicitly those of the predicate device, and the device performance is demonstrated through a comparison to ensure no new questions of safety or effectiveness are raised. Explicit, numerical acceptance criteria for clinical efficacy are not provided in this document as it's a 510(k) for an infrared lamp, which typically relies on established performance standards and comparison to a legally marketed predicate.

Feature / Acceptance Criteria Category	Reported Device Performance (OLIZ LTB-1000A)
Regulation Number	21CFR§890.5500, Infrared Lamp (Same as predicate)
Product Code	ILY (Same as predicate for relevant functions)
Indications for Use	For topical heating to elevate tissue temperature; for 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. (Same as predicate, excluding acne and wrinkle treatment)
Mechanism of Action	Use of red light for elevating tissue temperature and IR light. (Same as predicate, excluding blue light for acne and IR for wrinkles)
Maximum Device Surface Temperature	Less than 40°C
Wavelengths	655nm, 850nm (Predicate includes 465nm, 640nm, 880nm. Difference noted due to absence of blue light for acne in proposed device.)
Electrical Power	Use Li-ion batteries (3.7v_1800mA x2) (Predicate uses 110-120 V. Difference noted, safety proven by IEC 60601-1.)
Treatment Regimen	15 min. Twice a day (Total 210 min. per week) (Predicate: 3 times a week for 30 min., 4 weeks - Total 90 min. per week. Difference noted, performance/safety not affected when following recommended usage.)
Electrical Safety	Complies with IEC 60601-1 & collateral standards (Same as predicate)
Use	OTC (Same as predicate)
Biocompatibility	Patient contact materials tested for biocompatibility.
Design Specifications	Met all design specifications as verified by performance testing.
International/FDA Recognized Consensus Standards	Complies with 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.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical test set with human participants for determining the device's efficacy. The performance evaluation is based on non-clinical (bench) testing and comparison to a predicate device. Therefore, a sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As no clinical test set for efficacy/diagnostic performance was conducted, there were no experts used to establish ground truth in that sense. The "ground truth" for the device's substantial equivalence relies on established engineering standards and comparison with the predicate.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set with human data requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document states "Clinical performance: Not applicable."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, this device is an infrared lamp, not an algorithm, so the concept of standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is derived from:

Established industry standards: Specifically, international and FDA-recognized consensus standards for medical electrical equipment (IEC 60601 series), software (IEC 62304), and biological evaluation of medical devices (ISO 10993 series).
Performance of the predicate device: The BioPhotas Celluma3 (K152280) established the safety and effectiveness profile for similar infrared lamps, and the OLIZ LTB-1000A demonstrated equivalence to this predicate.

8. The Sample Size for the Training Set

Not applicable. This device is an infrared lamp; it does not involve machine learning or algorithms that require a "training set" of data. Testing was based on engineering and biocompatibility standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K221189

Device Name OLIZ LTB-1000A

Indications for Use (Describe)

				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)

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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

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3. PREDICATE DEVICE

Manufacturer	BioPhotas
Device Name (Trade Name)	Celluma3
510(k) Number	K152280

4. DEVICE DESCRIPTION

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 DeviceLTBIO OLIZ LTB-1000AK221189	Predicate DeviceBioPhotas Celluma3K152280	Analysis ofTechnologicalDifferences
Regulation No.	21CFR§890.5500,Infrared Lamp	21CFR§890.5500,Infrared Lamp	Same
Product Code	ILY	ILY, OHS, OLP	Same aspredicate deviceexcept forproduct codesOHS and OLPwhich areregarding acneand wrinklefeatures that ourproducts do nothave. Thus thisdifferencedoesn't affectthe safety andeffectiveness.
Indications foruse	The OLIZ LTB-1000A isintended to deliver heat in the	The BioPhotas Celluma3 isintended to deliver heat in	Same aspredicate device
Feature	Proposed DeviceLTBIO OLIZ LTB-1000AK221189	Predicate DeviceBioPhotas Celluma3K152280	Analysis ofTechnologicalDifferences
	IR spectrum to providetopical heating for thepurpose of elevating tissuetemperature; for thetemporary relief of minormuscle and joint pain,arthritis and muscle spasm;relieving stiffness; promotingthe relaxation of muscletissue; and to temporarilyincrease local bloodcirculation.	the IR spectrum to providetopical heating for thepurpose of elevating tissuetemperature; for thetemporary relief of minormuscle and joint pain,arthritis and muscle spasm;relieving stiffness;promoting the relaxation ofmuscle tissue; and totemporarily increase localblood circulation. The bluespectrum light is intended toreduce mild to moderateinflammatory acne vulgaris.The Celluma3 is intended toemit energy in the red andinfrared spectrum for use indermatology for thetreatment of periorbitalwrinkles.	except acnevulgaris andwrinklesfunction.
Mechanism ofAction	Use of red light for elevatingtissue temperature and IRlight.	Use of visible blue light intreatment of acne, red lightfor elevating tissuetemperature and IR light inimproving appearance ofperiorbital wrinkles.	Same aspredicate deviceexcept acnevulgaris andwrinklesfunction.
Maximum devicesurface temperature	Less than 40°C	Not publicly available	-
Wavelengths	655nm, 850nm	465nm, 640nm, 880nm	Predicate deviceincludes bluelight for acnetreatment notavailable in thesubject device.
Electrical power	Use Li-ion batteries(3.7v_1800mA x2)	110 - 120 V	This differencedoes not affectthe performanceof the product,and the safetyhas been provenby 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 differencedoes not affectthe performanceand safety of theproduct whenfollowing therecommendedusage times.
Electrical Safety	IEC 60601-1 & collateralstandards	IEC 60601-1 & collateralstandards	Same
Use	OTC	OTC	Same

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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.

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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

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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.

Regulation Number and Section

§ 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.