(147 days)
Not Found
No
The 510(k) summary describes a laser therapy system that delivers light energy for therapeutic purposes. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on temperature increase, which is a physical effect of the laser, not an AI/ML output.
Yes
The device is described as a "therapeutic medical laser" intended for "temporary relief of minor muscle and joint pain and stiffness," "temporary relief of minor joint pain associated with arthritis," and "relaxation of muscles," which are all therapeutic purposes.
No
The device is described as a therapeutic device intended for pain relief, increased circulation, and muscle relaxation through topical heating, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Multi-Channel Laser Therapy System" and describes physical components like "laser diode assembly hand-held" and "cup + laser diode assembly are put on the skin for treatment," indicating it is a hardware device that delivers light energy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the skin for therapeutic purposes (pain relief, increased circulation, muscle relaxation). This involves direct interaction with the patient's body.
- Device Description: The description confirms it's a noninvasive therapeutic laser that delivers light energy to the target tissue on the skin.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such analysis on specimens.
The device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Multi-Channel Laser Therapy System (Model no.: LA-1200) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The Multi-Channel Laser Therapy System LA-1200 is a noninvasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles. LA-1200 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility). LA-1200 contains twelve (12) channels of laser. For each channel of the Multi-Channel Laser Therapy System, LA-1200 makes use of cup + laser diode assembly hand-held to deliver the light energy to the designated treatment areas. The cup_+ laser diode assembly are put on the skin for treatment. Basic operation and treatment of LA-1200 is utilizing the laser module mounted in the cup (we call faser module cup) which will be hand-held and put on skin easily.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to demonstrate that the Multi-Channel Laser Therapy System (Model no.: LA-1200) increases the temperature of the skin exposed to the laser module cup and maintains a skin temperature of 40 ~ 45°C (104 ~ 113°F) following 15 minutes exposure to the light.
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
DEC 2 3 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
Submitter's Name: United Integrated Services Co., Ltd. 1
| 1. Submitter's Name: United Integrated Services Co., Ltd. | |
|---|---|
| Address: | 8F, No. 4, Alley 1, Lane 235, PaoChiao Road, Hsintien City, |
| Taipei Hsien, TAIWAN, 23144 | |
| Phone: | +886-2-2917-0366 ext 301 |
| Mobile Phone: | +886-9-11297250 |
| Fax: | +886-2-2917-4573 |
| Contact: | Mr. David O. Chang / Vice President |
| Contact E-mail: | david_chang@eod.uisco.com.tw |
| Prepare Date : | May 24,2010 |
| 2. Device Name: | |
| Trade Name: | Multi-Channel Laser Therapy System, |
| Model no.: LA-1200 | |
| Common Name: | Laser Therapy |
| Classification name | lamp, infrared, therapeutic heating |
| 3. DEVICE CLASS | The Multi-Channel Laser Therapy System, |
| (Model no.: LA-1200) has been classified as | |
| Regulatory Class: II | |
| Product Code: ILY |
Requlation Number: 21CFR 890.5550
-
Predicate Device:
-
Intended Use:
The predicate device is the Multi-Channel Laser Therapy System, MODEL LA-400 (K082686) marketed by United Integrated Services Co., Ltd.
The Multi-Channel Laser Therapy System (Model no.: LA-1200) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
- Device Description: The Multi-Channel Laser Therapy System LA-1200 is a noninvasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
Product: Multi-Channel Laser Therapy System, Model #: LA-1200 2010/12/03 REV. (B) Section 5 - 510(k) Summary Page 1 of 2
1
LA-1200 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility).
LA-1200 contains twelve (12) channels of laser. For each channel of the Multi-Channel Laser Therapy System, LA-1200 makes use of cup + laser diode assembly hand-held to deliver the light energy to the designated treatment areas. The cup_ + laser diode assembly are put on the skin for treatment.
Note A : Basic operation and treatment of LA-1200 is utilizing the laser module mounted in the cup (we call faser module cup) which will be hand-held and put on skin easily.
- Performance In terms of operating specification, Safety & EMC Summary: requirements, the device conforms to applicable standards included ISO 13485, IEC 60825-1, IEC 60601-1 and IEC 60601-1-2 requirements.
As shown from the Appendix 11-8 to Appendix 11-13, the bench testing was also performed to demonstrate that the Multi-Channel Laser Therapy System (Model no.: LA-1200) increases the temperature of the skin exposed to the laser module cup and maintains a skin temperature of 40 ~ 45°C (104 ~ 113°(' ) following 15 minutes exposure to the light.
8. Conclusions:
The Multi-Channel Laser Therapy System (Model no.: LA-1200) has the same intended use and similar technological characteristics as the Multi-Channel Laser Therapy System, MODEL LA-400 (K082686) marketed by United Integrated Services Co., Ltd. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new guestions of safety or effectiveness. Thus, the Multi-Channel Laser Therapy System (Model no.: LA-1200) is substantially equivalent to the predicate devices.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
United Integrated Services Corporation Ltd. % Mr. David O. Chang Vice President 8F, No. 4, Alley 1, Lane 235 Paochiao Road, Hsintien City Taipei Hsien, Taiwan, R.O.C. 23144
DEC 2 3 230
Re: K102134
Trade/Device Name: Multi-Channel Laser Therapy System Model no .: LA-1200 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: December 14, 2010 Received: December 17, 2010
Dear Mr. Chang:
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. Iisting 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.
Comments of Children
3
Page 2 - Mr. David O. Chang
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 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 Patt 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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 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 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.
Aj B. Rh
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K102134
Device Name: Multi-Channel Laser Therapy System Model no.: LA-1200 United Integrated Services Co. Ltd.
Indications for Use:
The Multi-Channel Laser Therapy System (Model no.: LA-1200) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Az : B. Rh In 17x17
(Division Sign-Ong Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K102134