(72 days)
Not Found
No
The summary describes a standard infrared therapy device with basic software control, and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details about training or test sets typically associated with AI/ML development.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation," which describes therapeutic benefits.
No
The device description and intended use indicate that it is a therapy device (infrared therapy for pain relief and circulation), not a diagnostic one. It emits energy rather than collecting data for diagnosis.
No
The device description explicitly states it is composed of an emitter, probe, and on/off button, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic device that applies energy to the body for pain relief and increased blood circulation. This is a therapeutic device, not a diagnostic one.
- Device Description: The description of the device as an "infrared therapy device" that emits light for treatment further supports its therapeutic nature.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Klaser provides infrared therapy for the following allowed claims: Infrared therapy to provide topical heating for: - Temporary increase in local blood circulation - Temporary relief of minor muscles and joint aches, pains and stiffness - Relaxation of muscles . - Muscles spasms - Minor pain and stiffness associated with arthritis - The intended Use/Indications For Use stated herein are identical to the cleared indications for the predictae levice.
The device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
Product codes
ILY
Device Description
Klaser is an infrared therapy device, composed of emitter, software, probe for the delivery of light and an on/off button to activate and deactivate the infrared emission.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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) K-LASER HEAT LAMP Nº 9067781 SECTION E: 510 (K) STATEMENT OR SUMMARY
050070 1 of 2
MAR 2 5 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
UBMITTED BY: ELTECH s.r.l.
Via Castagnole, 20/H 31100 Treviso Italy Phone: 0039 422 210 430 Fax: 0039 422 297 137
I DEVICE NAME (Trade/common, and classification): Klaser Therapy Probe.
Classification: Class II Regulation Nos.: 890.5500 Product Codes: ILY
2. PREDICATE DEVICES:
ALT Laser, Model VTR 75 - Cleared under K031613 Vectra Genisys Laser System - Cleared under K 040662 Solaris D890 - Cleared under K040729
- PERFORMANCE STANDARDS: Klaser conforms to the applicable requirements of 21 CFR section 1010 న. (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products).
- DESCRIPTION: Klaser is an infrared therapy device, composed of emitter, software, probe for the delivery ঞ্চ of light and an on/off button to activate and deactivate the infrared emission.
1
510(K) K-LASER HEAT LAMP Nº 9067781 SECTION E: 510 (K) STATEMENT OR SUMMARY
K050070 2 of 2
-
INTENDED USE/ INDICATIONS FOR USE: Klaser provides infrared therapy for the following allowed 5 claims:
Infrared therapy to provide topical heating for: -
Temporary increase in local blood circulation -
-
Temporary relief of minor muscles and joint aches, pains and stiffness -
-
Relaxation of muscles .
-
Muscles spasms ﺘ
-
Minor pain and stiffness associated with arthritis -
'he intended Use/Indications For Use stated herein are identical to the cleared indications for the predictae levice.
- SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: K-Laser generates infrared therapy for treatment of , o GBC PANY Williams and shares the same or similar basic characteristics and the same intended sciouralized the proposed K-Laser is substantially equivalent to the Solans ass as the products
D890, cleared under K040729; to ALT Laser Model VTR 75, deared under K031612; to Vectra Genisys Laser System, cleared under K04066. -
- SAFETY AND EFFECTIVENESS: There are no substantive differences between the products defined in SHE EPT This 2011 - 1 in other similar medical devices. They were developed and documented under Eltech's mature Quality m other of million.
Managerment System, under The Quality System Regulation, 21 CFR Part 820, under design/change control, and verified/validated to applicable standards/guidance documents. Besides, Eltech's Quality Assurance System is certified by CERMET, notified body n. CE 0476, according to Annex II of 93/42 EEC Directive, transposed in Italy by Digs. n. 46 of 24 February 1997. Klaser is safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program.
- SAFETY AND EFFECTIVENESS: There are no substantive differences between the products defined in SHE EPT This 2011 - 1 in other similar medical devices. They were developed and documented under Eltech's mature Quality m other of million.
Signed:__.
Fitechs r.l. rancesco Zanata President
Date: 12-7-2004
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human face in profile, composed of three curved lines.
Public Health Service
MAR 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eltech s.r.l. c/o Mr. Richard Albright Laser Therapy Products 1510 Towne Park Lane Franklin, Tennessee 37067
Re: K050070
Trade/Device Name: Klaser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: February 18, 2005 Received: February 22, 2005
Dear Mr. Albright:
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.
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. I'l // 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 nust 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.
3
Page 2 - Mr. Richard Albright
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the 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 yours,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) K-LASER HEAT LAMP Nº 9067781 SECTION D: STATEMENT OF INDICATION FOR USE
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: KLASER
Indications for Use:
The device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K650070
D - Page 1 of 1