OLIZ LTB-1000A

K221189 · Ltbio Co., Ltd. · ILY · Aug 29, 2022 · Physical Medicine

Device Facts

• Record ID: K221189
• Device Name: OLIZ LTB-1000A
• Applicant: Ltbio Co., Ltd.
• Product Code: ILY · Physical Medicine
• Decision Date: Aug 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

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 the relaxation of muscle tissue; and to temporarily increase local blood circulation.

Device Story

OLIZ LTB-1000A is a shapeable LED panel; fits anatomical contours; uses red (655nm) and near-infrared (850nm) light to elevate tissue temperature; includes soothing vibration function. Device is for over-the-counter (OTC) use; operated by patient. Input is electrical energy from Li-ion batteries; output is thermal energy and vibration. Healthcare providers do not operate device; output is used by patient for self-administered pain relief and muscle relaxation. Benefits include temporary pain relief and improved local circulation.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via electrical safety (IEC 60601-1, 60601-1-2, 60601-1-11), software lifecycle (IEC 62304), and biocompatibility (ISO 10993-1, 5, 10) testing. Device surface temperature confirmed < 40°C.

Technological Characteristics

Shapeable LED panel; wavelengths 655nm (red) and 850nm (IR); power source 3.7V Li-ion batteries (1800mA x2); biocompatible materials; vibration function. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, stiffness, and to promote muscle relaxation and increase local blood circulation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BioPhotas Celluma3 (K152280)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

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.

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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: [phone] . Fax: [phone]

#### 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: [phone] . Fax: [phone]
- . E-mail: [e-mail]

# 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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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<br>LTBIO OLIZ LTB-1000A<br>K221189 | Predicate Device<br>BioPhotas Celluma3<br>K152280 | Analysis of<br>Technological<br>Differences |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation No. | 21CFR§890.5500,<br>Infrared Lamp | 21CFR§890.5500,<br>Infrared Lamp | Same |
| Product Code | ILY | ILY, OHS, OLP | Same as<br>predicate device<br>except for<br>product codes<br>OHS and OLP<br>which are<br>regarding acne<br>and wrinkle<br>features that our<br>products do not<br>have. Thus this<br>difference<br>doesn't affect<br>the safety and<br>effectiveness. |
| Indications for<br>use | The OLIZ LTB-1000A is<br>intended to deliver heat in the | The BioPhotas Celluma3 is<br>intended to deliver heat in | Same as<br>predicate device |
| Feature | Proposed Device<br>LTBIO OLIZ LTB-1000A<br>K221189 | Predicate Device<br>BioPhotas Celluma3<br>K152280 | Analysis of<br>Technological<br>Differences |
| | IR spectrum to provide<br>topical heating for the<br>purpose of elevating tissue<br>temperature; for the<br>temporary relief of minor<br>muscle and joint pain,<br>arthritis and muscle spasm;<br>relieving stiffness; promoting<br>the relaxation of muscle<br>tissue; and to temporarily<br>increase local blood<br>circulation. | the IR spectrum to provide<br>topical heating for the<br>purpose of elevating tissue<br>temperature; for the<br>temporary relief of minor<br>muscle and joint pain,<br>arthritis and muscle spasm;<br>relieving stiffness;<br>promoting the relaxation of<br>muscle tissue; and to<br>temporarily increase local<br>blood circulation. The blue<br>spectrum light is intended to<br>reduce mild to moderate<br>inflammatory acne vulgaris.<br>The Celluma3 is intended to<br>emit energy in the red and<br>infrared spectrum for use in<br>dermatology for the<br>treatment of periorbital<br>wrinkles. | except acne<br>vulgaris and<br>wrinkles<br>function. |
| Mechanism of<br>Action | Use of red light for elevating<br>tissue temperature and IR<br>light. | Use of visible blue light in<br>treatment of acne, red light<br>for elevating tissue<br>temperature and IR light in<br>improving appearance of<br>periorbital wrinkles. | Same as<br>predicate device<br>except acne<br>vulgaris and<br>wrinkles<br>function. |
| Maximum device<br>surface temperature | Less than 40°C | Not publicly available | - |
| Wavelengths | 655nm, 850nm | 465nm, 640nm, 880nm | Predicate device<br>includes blue<br>light for acne<br>treatment not<br>available in the<br>subject device. |
| Electrical power | Use Li-ion batteries<br>(3.7v_1800mA x2) | 110 - 120 V | This difference<br>does not affect<br>the performance<br>of the product,<br>and the safety<br>has been proven<br>by IEC 60601-1 |
| Treatment | | | |
| | 15 min. Twice a day<br>(Total 210 min. per week) | 3 times a week for 30 min.<br>4 weeks<br>(Total 90 min. per week) | This difference<br>does not affect<br>the performance<br>and safety of the<br>product when<br>following the<br>recommended<br>usage times. |
| Electrical Safety | IEC 60601-1 & collateral<br>standards | IEC 60601-1 & collateral<br>standards | Same |
| Use | OTC | OTC | Same |

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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.

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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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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.