(238 days)
The Multi-Channel Laser Therapy System (Model no.: LA-400) 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.
The Multi-Channel Laser Therapy System LA-400 is a noninvasive, conamic casel Therapy System LA-400 is a not deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minored spectrum for the purpos temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where arthritis, for the temporary increase in le l Lacer The (Model no.: LA-400) is interapy System infrared spectrum to provide to emit energy in the infrared spectrum to provide topical heating for the of elevating tissue temporature for the purpose of elevating tissue temperature for the temporary relief of temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied minor muscle and the joint pain and stiffness, for the temporary relia temporary relief of miner in in in in the LA-400 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility). LA-400 contains four (4) channels of laser. For each channel of the Multi-Channel Laser Therapy System , LA-400 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-400 is utilizing the laser module mounted in the cup (we call laser module cup) which will be hand-held and put on skin easily.
The provided 510(k) summary for the Multi-Channel Laser Therapy System, Model no.: LA-400, focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and conformance to safety and EMC standards. It does not contain information about a clinical study involving human participants, performance metrics like sensitivity or specificity, or any form of a multi-reader multi-case (MRMC) study.
Therefore, many of the requested sections regarding acceptance criteria and a study proving those criteria cannot be directly answered from the provided text. The "performance summary" in this document refers to compliance with engineering and safety standards, not a clinical performance study in the way typically associated with diagnostic or AI-powered devices.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria and reported "performance" for this device, as described in the 510(k) summary, are related to its adherence to electrical safety and electromagnetic compatibility (EMC) standards, not clinical efficacy or diagnostic accuracy.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance |
|---|---|
| ISO 13485 (Quality Management System) | Conforms |
| IEC 60825-1 (Laser Safety) | Conforms |
| IEC 60601-1 (Medical Electrical Equipment - Basic Safety and Essential Performance) | Conforms |
| IEC 60601-1-2 (Medical Electrical Equipment - Electromagnetic Compatibility) | Conforms |
| Clinical Efficacy for Intended Use | Demonstrated by substantial equivalence to predicate device (ACUMED LASER, MODEL 1000, K060153) based on similar intended use and technological characteristics. Bench testing confirmed differences do not raise new safety/effectiveness questions. |
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set data is described in this 510(k) summary. The performance summary refers to bench testing for conformance to standards, not a clinical study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of a test set requiring expert ground truth in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done, as this is a laser therapy system for pain relief, not a diagnostic imaging device typically associated with such studies. The device does not involve AI or human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical therapy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth data is discussed for this device in the provided text. The "ground truth" for this submission revolves around compliance with established engineering and safety standards for medical devices and demonstration of similar intended use and technology to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth for one.
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510(K) SUMMARY K082686
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR ? 07.92
- Submitter's Name: United Integrated Services Co., Ltd. 1.
| Address: | 3F, No. 4, Lane 7, PaoKao Road, Hsintien City, Taipei Hsien,TAIWAN, 23144 |
|---|---|
| Phone: | +886-2-2917-4060 ext 8301 |
| 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 : | Feb.24,2009 |
Multi-Channel Laser Therapy System,
Regulation Number: 21CFR 890.5550
-
- Device Name:
Trade Name:
- Device Name:
Model no.: LA-400 1 Common Name: Laser Therapy Classification name lamp, infrared, therapeutic heating
-
- DEVICE CLASS
- The Multi-Channel Laser Therapy System, (Model no.: LA-400) has been classified as Regulatory Class: II Product Code: ILY
-
- Predicate Device:
-
- Intended Use:
and the relaxation of muscles. 6. Device Description: The Multi-Channel Laser Therapy System LA-400 is a noninvasive, conamic casel Therapy System LA-400 is a not deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minored spectrum for the purpos
temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where arthritis, for the temporary increase in le
l Lacer The
The predicate device is the ACUMED LASER, MODEL 1000
(Model no.: LA-400) is interapy System
infrared spectrum to provide to emit energy in the infrared spectrum to provide topical heating for the
of elevating tissue temporature for the purpose of elevating tissue temperature for the temporary relief of
temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied
minor muscle and the joint pain and stiffness, for the temporary relia
temporary relief of miner in in in in the
(K060153) marketed by LASER THERA, LLC..
The Multi-Channel Laser Therapy System
Page 1 of 2
Product : Multi-Channel Laser Therapy System , Model #: LA-400
2009/4/24 Section 4 - 510(k) Summary
REV.【D】
{1}------------------------------------------------
LA-400 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility).
LA-400 contains four (4) channels of laser. For each channel of the Multi-Channel Laser Therapy System , LA-400 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-400 is utilizing the laser module mounted in the cup (we call laser module cup) which will be hand-held and put on skin easily.
-
- Performance Summary:
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included ISO 13485, IEC 60825-1, IEC 60601-1 and IEC 60601-1-2 requirements.
- Performance Summary:
8. Conclusions:
The Multi-Channel Laser Therapy System (Model no.: LA-400) has the same intended use and similar technological characteristics as the ACUMED LASER, MODEL 1000 (K060153) marketed by LASER THERA, LLC.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Multi-Channel Laser Therapy System (Model no.: LA-400) is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the emblem.
Public Health Service
MAY 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
United Integrated Services Co., Ltd. % Mr. David O. Chang Vice President 3F, No. 4, Lane 7, Pao-Kao Road Hsintien City, Taipei Hsien Taiwan, 23144
Re: K082686
Trade/Device Name: Multi-Channel Laser Therapy System Model no .: LA-400 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Codc: IL Y Dated: April 28, 2009 Received: April 29, 2009
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. David O. Chang
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Mark N. Melkerson
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082686
Device Name: Multi-Channel Laser Therapy System Model no.: LA-400 United Integrated Services Co., Ltd.
Indications For Use:
The Multi-Channel Laser Therapy System (Model no.: LA-400) 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.
| Prescription Use(Part 21 CFR 801 Subpart D) | V AND/OR |
|---|---|
| ------------------------------------------------- | ---------- |
Over-The-Counter Use (21 CFR 807 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil Kpogl formxm
(Division Sign-Off)
Page 1 of 1
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K 082686
N/A