(44 days)
Not Found
No
The description focuses on the physical components and function of an infrared lamp for topical heating, with no mention of AI or ML.
Yes
The device is described as an infrared lamp intended to provide topical heating for the temporary relief of pain and stiffness, increase circulation, and relax muscles, all of which are therapeutic uses.
No
The device is intended for therapeutic purposes (topical heating for pain relief, increased circulation, muscle relaxation) rather than diagnosing conditions.
No
The device description clearly states it consists of hardware components: a control base unit, infrared heat lamp probes, and a power adapter.
Based on the provided text, the Clini-Lase System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device that applies topical heating to the body for therapeutic purposes (pain relief, circulation, muscle relaxation). This is an in-vivo application, meaning it interacts with a living organism.
- Device Description: The description details an infrared lamp system that emits energy for heating. This aligns with a physical therapy or medical device used on the body, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. The Clini-Lase System directly interacts with the body.
N/A
Intended Use / Indications for Use
The Clini-Lase System is an infrared lamp that is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperture for the temporary relief of minor muscle and 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. In addition, the Clini-Lase System may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Product codes
ILY, GEX
Device Description
The Clini-Lase System consists of a clinical and portable control base unit, and seperate attachment infrared heat lamp probes. The control base unit houses the electronics, LCD display and system controls and is powered by 12 Volts DC suplied by an AC-DC Power Adapter. The attachment probes produce infrared radiation to provide topical heating. Various single and cluster probes are available for the base units. The probes are conected by a readily replacable independent cable assembly.
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
The differences in the specifications of the Clini-Lase System and the predicate devices do not result in different performance or raise new questions of safety or efficacy.
Potentail hazards are identified and have been mitigated by design and labeling.
Key Metrics
Not Found
Predicate Device(s)
K032231, K033923, K040662, K043586, K050370
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Premarket Notification for the Clini-Lase
2
510(k) Summary of Saftey and Effectiveness
1. Submitter's Name and Address
American Spine Center, Ltd. 100 Mascoutah Avenue Belleville, IL 62220-3801 Phone: 618-233-6824 Fax: 618-233-6825
Key Contact: James J. White, President
Date Prepared: 09/22/2005
2. Device Name
Proprietary Name: Clini-Lase Laser System Common / Usual Name: Infrared Lamp Classification Name: Infrared Lamp (21 CFR 890.5500) Product Code: ILY
Model #: CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-Base, CLP-275 and CLP-55.
3. Legally-Marketed Predicate Devices
The Clini-Lase System are substantially equivalent to other infrared sources (product code ILY) currently in commercial distribution such as:
K032231 MedX LCT100 & MedX LCS Portable Laser K033923 Thor DDII IR Lamp Systems K040662 Vectra Genisis Laser System
K043586 Laser Sys*Stim 540, Model ME 540
K050370 Palomar LuxIR Handpiece
Description of the Device
The Clini-Lase System consists of a clinical and portable control base unit, and seperate attachment infrared heat lamp probes. The control base unit houses the electronics, LCD display and system controls and is powered by 12 Volts DC suplied by an AC-DC Power Adapter. The attachment probes produce infrared radiation to provide topical heating. Various single and cluster probes are available for the base units. The probes are conected by a readily replacable independent cable assembly.
1
052647 2 of 2
510(k) Premarket Notification for the Clini-Lase System
4. Intended Use of the Device
The Clini-Lase System is an infrared lamp that is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperture for the temporary relief of minor muscle and 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. In addition, the Clini-Lase System may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
5. Performance Data
The differences in the specifications of the Clini-Lase System and the predicate devices do not result in different performance or raise new questions of safety or efficacy.
6. Non-clinical Data
Potentail hazards are identified and have been mitigated by design and labeling.
7. Conclusion
Based on the foregoing, the Clini-Lase System is substantially equivalent to the legally-marketed predicate devices.
2
Name of Manufacturer: American Spine Center, LTD. Laser Model Name and Number: Clini-Lase System CL-2000, CL-1200, CL-155, CL-500. CL-300, CL-275, CL-55
Laser Type: (Circle all that apply)
Alexandrite, Argon, CO2, Copper-Vapor, Diode, Dye, Nd:YAG, Erbium, Hol: YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other
CED's ________________________________________________________________________________________________________________________________________________________________________
Indications in this application: The Clini-Lase System is an infrared lamp that 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 joint pain associated with arthritis, for the temporary increase in local circulation where applied, and the relaxation of muscles, minor sprains and strains, and minor muscular back pain.
FDA Document Control Number: K052647
FDA Product Code: 79GEX
Reviewer Computer Initials: CYH
Date of Clearance Letter: 11/04/05
Basis of Approval: (Circle all that apply)
Predicate Device (PD), Clinical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Test Data (BTD), Historical Information (HI), Other
Description of Laser: Operation Modes: (Circle all that apply) CW, Pulsed Q-Switched, Mode Locked, Contact, Free Beam, Other ________________________________________________________________________________________________________________
Wavelength in Nanometers: 808, 650, 785
Power/Energy Range (Watts/Joules): 25 mW - 500 mW
Pulse Width: n/a
Repitition Rate: n/a
Delivery System: hand held probes Comments:
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2005
James J. White President American Spine Center, LTD. Clini-Lase 100 Mascoutah Avenue Belleville, Illinois 6220-3801
Re: K052647
Trade/Device Name: Clini-Lase Systems, with Models: CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, and CL-55 CLP-Base, CLP-275 and CLP-55
Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 31, 2005 Received: October 31, 2005
Dear Mr. White:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2- James J. White
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and w your e FDA finding of substantial equivalence of your device to a legally prematted predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you attire Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Sincerely yours,
Barbaze Buehup
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K092647/5
510(k) Premarket Notification for the Clini-Lase System
Indication for Use:
K052647
510(k) Number (if known):
Device Name:
Clini-Lase System, with Models:
CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, and CL-55.
CLP-Base, CLP-275 and CLP-55.
Indication For Use:
The Clini-Lase System is an infrared lamp that is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperture for the temporary relief of minor muscle and 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. In addition, the Clini-Lase System may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, OFFICE of Device Evaluation (ODE)
Tarbayemohmd
Division of General, Restorative, and Neurological Devices
510(k) Number K052647
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