Collagentex Rx-1

K162022 · Tanses Technologies, Inc. · NHN · Dec 22, 2016 · Physical Medicine

Device Facts

• Record ID: K162022
• Device Name: Collagentex Rx-1
• Applicant: Tanses Technologies, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Dec 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Collagentex RX-1 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Device Story

Collagentex RX-1 is a stand-alone near-infrared lamp system; emits polychromatic visible to near-infrared light (580nm-1500nm) via quartz lamp. Device features non-collimating, non-pulsing light output; includes narrow-band filter and acrylic shield to block UV/wavelengths <480nm. Operated by clinician or user; unit mounted on table or caster base. User sets timer for 20-minute treatment sessions at minimum 8-inch distance. Output intensity is 44.2 mW/cm² (2.6 J/min). Device provides non-topical, non-contact light therapy; intended to provide temporary relief of minor chronic neck and shoulder pain. Benefits include non-invasive, non-heating adjunctive pain management.

Clinical Evidence

Bench testing only. Device performance validated through electrical safety (NRTL, CSA, ANSI), electromagnetic compatibility (IEC 60601-1-2 3rd ed.), and photobiological safety (ANSI/IESNA RP-27.1-05 and RP-27.3-07) testing. Irradiation parameters (20 cm distance, 20-minute duration) confirmed to maintain skin surface temperature below 42°C.

Technological Characteristics

Quartz halogen lamp light source (500W); wavelength 580nm-1500nm. Non-polarized output. Includes narrow-band filter and acrylic shield. AC power (120V/220V). Dimensions: 23cm diameter exposure area. Standards: IEC 60601-1-2 (EMC), ANSI/IESNA RP-27.1-05 (photobiological safety), ANSI/IESNA RP-27.3-07 (eyewear safety), ISO 13485/14971 (risk analysis). Non-contact device.

Indications for Use

Indicated for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin in patients requiring non-heating adjunctive light therapy.

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

• Bioptron Pro Light Therapy system (K032216)
• Bioptron Compact III Light Therapy System (K032216)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2016

Tanses Technologies. Inc. Mr. Kirk Kiremitci President 4450 Highway 13 Laval, Quebec, Canada H7R 6E9

Re: K162022

Trade/Device Name: Collagentex Rx-1 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: NHN Dated: November 25, 2016 Received: November 29, 2016

Dear Mr. Kiremitci:

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 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 (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

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forth in the quality systems (QS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K162022

Device Name

Collagentex RX-1

Indications for Use (Describe)

Collagentex RX-1 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

#### Date Prepared

August 1, 2016

#### Submitter Information

Tanses Technologies inc. 4450 Highway 13 Laval, Quebec H7R 6E9 Canada Tel: [phone] Fax number: 450-622-1540 Contact name: Kirk Kiremitci Email: [e-mail]

#### Device Information

| Device Trade Name: | Collagentex |
|---------------------|------------------------------------------------------|
| Device Model Name: | RX-1 |
| Common /Usual Name: | Near Infrared Lamp |
| Regulation Name: | Lamp, non heating, for adjunctive use in pain relief |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 890.5500 |
| Product Code: | NHN |
| Panel: | Physical Medicine |

#### Predicate Device

| Submitter: | Bioptron AG, Switzerland |
|---------------|---------------------------------------------------------------------------------|
| Manufacturer: | Bioptron AG, Switzerland |
| Trade Name: | Bioptron |
| Model: | Bioptron Pro Light Therapy system,<br>Bioptron Compact III Light Therapy System |
| Product Code: | NHN |
| 510(k): | K032216 |

#### Device Description

Collagentex RX-1 model is a stand alone device of a single quartz lamp, emitting polychromatic visible to near infrared light from 580nm to 1500nm, non-collimating, non pulsing in order to offer exposure to the user where directed at a distance of 8" and farther from the body, non topical light therapy in order to relieve minor pain temporarily. The unit can be mounted on a table top or rolled on a base with casters. Narrow band filter and acrylic shield are designed to eliminate any

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emission of ultraviolet or wavelength shorter than 480nm wavelengths. The lamp

replacement life is 500hrs. The exposure dosage is controlled by a user set timer. Exposure area is set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute of exposure at the minimum distance. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.

## Intended Use

Collagentex RX-1 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

#### Technical Characteristics

| Characteristics | Collagentex Rx-1 | Bioptron Pro Light &<br>Compact III |
|-----------------------------------------|------------------------------------------|----------------------------------------|
| Light source | Quartz Lamp | Quartz Lamp |
| Light Source Power | 500 W | 90 W |
| Exposure area | 23cm diameter (4.37 times<br>larger) | 11cm diameter |
| Emitted light wavelength<br>(effective) | 580nm to 1500nm | 590nm to 1550nm |
| Emitted light polarization | Not polarized | Polarized >95% |
| Indications of use | temporary pain relief | temporary pain relief |
| Product code | NHN | NHN |
| Emitted light intensity | 44.2 miliWatt/sqcm (2.6<br>Joule/minute) | 40 miliWatt/sqcm (2.4<br>Joule/minute) |
| Power supply | 120 VAC or 240 VAC | 120 VAC or 240 VAC |
| Design Principle | Quartz halogen lamp with a<br>filter | Quartz halogen lamp with a<br>filter |
| Skin Surface Temperature | Under 42 C | Under 42 C |
| Treatment Time | 20 minutes | 20 minutes |
| Patient Contact | No contact to human body | No contact to human body |
| Biocompatibility | No contact to human body | No contact to human body |
| Electrical Safety | NRTL, CSA, ANSI | CE |
| Electromagnetic<br>Compatibility | 60601-2 (3rd ed.) | CE |
| Risk Analysis | According to ISO<br>13485/14971:2007 | CE |
| Photobiological safety of<br>the device | IESNA/ANSI RP-27.1-05 | CE |
| Photobiological safety of<br>eyewear | IESNA/ANSI RP-27.3-07 | CE |

From the comparison form above, the subject device and the predicate device have the same indications for use, operation principle, skin temperature, wavelength spectrum, irradiation intensity and treatment time.

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The subject device has been tested and complied with the following voluntary recognizable standards IEC60601-1-2 3rd edition Electromagnetic compatibility requirements as well NRTL, CSA, ANSI electrical safety standards and ANSI/IESNA RP-27.1-05 and ANSI/IESNA RP-27.3-07 photobiological safety standards for the device and the eye protection.

According to the test result in this submission, the irradiation distance is 20 cm and the irradiation time is 20 minutes and the skin temperature is less than 42 C degrees.

## Conclusion

Collagentex RX-1 model is substantially equivalent to the predicate device in K032216.