(191 days)
Not Found
No
The document describes a laser system for pain relief and does not mention any AI or ML components or functionalities.
Yes
The device is described as a medical laser system intended to provide therapeutic benefits such as pain relief, increased local blood circulation, and muscle relaxation. The "Intended Use / Indications for Use" section explicitly states these therapeutic purposes.
No
The device is described as providing "topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle." This indicates a therapeutic, not diagnostic, function.
No
The device description clearly outlines physical hardware components including a laser source, fiber optics, handpiece, warning light, and specifies physical dimensions and weight.
Based on the provided information, the ASA laser SH1 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle." This describes a therapeutic application directly on the human body.
- Device Description: The description details a medical laser system that delivers radiation to a "treatment area" through a handpiece. This is consistent with a device used for direct treatment of a patient.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The ASA laser SH1 does not perform this function.
The ASA laser SH1 is a therapeutic medical device used for direct treatment of patients, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The ASA laser SH1 is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Product codes
ILY
Device Description
The ASA laser SH1 is a medical laser system equipped with a Nd: Y AG laser source.
The Nd:YAG laser radiation has a wavelength of 1064nm and is delivered to the treatment area through a fiber optics and a delivery handpiece connected to its distal end.
A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready.
Overall weight of the device is 13 kg, and the size is 38 cm x 22 cm x 42 cm (H x W x D).
Electrical requirement is 115Vac 50/60Hz, 750VA.
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
A clinical study has been performed on three live human subjects with three different skin phototypes. The study has shown that ASA laser SH1 is able to induce a skin temperature between 40℃ and 45°C and maintain that temperature for at least 10 minutes for all patients.
The results of clinical performance tests show that ASA laser SH1 system is as safe, as effective and performs as well as its predicate device for the indications for use mentioned above.
Key Metrics
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
K122/25
510(K) Summary
JAN 2 5 2013
Submitter:
El.En. S.p.A.
via Baldanzese, 17
50041 Calenzano (FI), Italy
Contact:
Paolo Peruzzi
Regulatory Affairs Manager
Phone: +39.055.8826807
E-mail: standards@elen.it
Date Summary Prepared:
Device Trade Name:
Common Name:
Classification Name:
Equivalent Devices:
Device Description:
November 26, 2012
ASA laser SH1
Nd:YAG Laser System
Infrared Lamp
ILY, 21 CFR 890.5500
HILT Family Laser (K051537)
The ASA laser SH1 is a medical laser system equipped with a Nd: Y AG laser source.
The Nd:YAG laser radiation has a wavelength of 1064nm and is delivered to the treatment area through a fiber optics and a delivery handpiece connected to its distal end.
A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready.
Overall weight of the device is 13 kg, and the size is 38 cm x 22 cm x 42 cm (H x W x D).
Electrical requirement is 115Vac 50/60Hz, 750VA.
1
Indications for Use:
Comparison:
Nonclinical Performance Data:
Clinical Performance Data:
.
The ASA laser SH1 is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
The ASA laser SH1 is substantially equivalent to its predicate device.
It shares same indication for use, same principle of operation essentially same technological and characteristics and performances.
None
A clinical study has been performed on three live human subjects with three different skin phototypes. The study has shown that ASA laser SH1 is able to induce a skin temperature between 40℃ and 45°C and maintain that temperature for at least 10 minutes for all patients.
The results of clinical performance tests show that ASA laser SH1 system is as safe, as effective and performs as well as its predicate device for the indications for use mentioned above.
Additional Information:
Conclusion:
None
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or supporting another, represented by flowing lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
EL.EN. Electronic Engineering S.p.A % Mr. Paolo Peruzzi · Regulatory Affairs Manager 17 Via Baldanzese Calenzano, Italy 50041
Re: K122125
Trade/Device Name: ASA laser SH1 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: IL Y Dated: November 27, 2012 Received: November 29, 2012
Dear Mr. Peruzzi:
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 t 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
January 25, 2013
3
Page 2 – Mr. Paolo Peruzzi
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 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/ReportalProblem/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,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) Number (if known):
Device Name: ASA laser SHI
Indications for Use:
The ASA laser SHI is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Prescriptive Use _ X (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C) ti
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(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence ofCDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2013.01.25 08:10:41 -05'00'
(Division Sign-Off)
Division of Surgical Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________ K122125