(344 days)
Not Found
No
The device description focuses on the physical components and laser technology, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device description explicitly labels it as a "therapeutic medical laser," and its intended use is for "temporary relief of pain," which is a therapeutic purpose.
No
The device is indicated for pain relief, not for diagnosing a condition.
No
The device description explicitly states it is a handheld laser device with a control unit and hand-held probes, indicating it is a hardware device that utilizes laser technology.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice." This describes a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "handheld, non-invasive, low energy, non thermal infrared therapeutic medical laser." This further reinforces its therapeutic nature.
- Classification: The device is classified under 21 CFR 890.5500, NHN as a "non-heating infrared lamp for adjunctive use in pain therapy." This classification is for physical medicine devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The LightStream Low Level Laser device is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
Product codes (comma separated list FDA assigned to the subject device)
NHN
Device Description
The LightStream Laser is a handheld, non-invasive, low energy, non thermal infrared therapeutic medical laser. The LightStream Laser System incorporates an AC or battery powered Control Unit and a hand-held laser diode probe with one laser tip and one cluster probe with 5 laser tips. The device incorporate Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering 60mW at the 903 nanometer (nm) wavelength, classifying it under under 21 CFR 890.5500, NHN as non-heating infrared lamp for adjunctive use in pain therapy. The LightStream is a non thermal device and is intended to be for adjunctive use in pain therapy and is not intended to provide therapeutic topical heating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Safety and performance testing was performed on the LightStream Low level Laser. The testing has demonstrated that the device complies with both safety and performance FDA recognized consensus standards that apply to the LightStream Low Level Laser. The LightStream Low level Laser has been tested and complies with the following standards:
General Safety standard: IEC 60601-1: 2005
EMC IEC 60601-1-2: 2001
Medical Laser Equipment: IEC 60601-2-22: 2007
CE Marking Classification: Medical Device Directive Ilb, Certificate No. C10151
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
Koyll66
510 k Notification: Solica Corp LightStream Laser
4/01/2009
Section 5: 510(k) Summary
l.
APR – 3 2009
| General Information: | ||
|---|---|---|
| Proprietary Name: | LightStream Low Level Laser | |
| Common / Usual Name: | Infrared Low Level Laser System | |
| Device Classification: | 21 CFR 890.5500 Infrared Lamp, Non- | |
| Heating | ||
| Product Code: | NHN | |
| Applicant Name & Address: | ||
| Solica Inc. | ||
| 129 Yorkville Avenue, Suite 300 | ||
| Toronto, Ontario M5R 1C4 | ||
| Telephone: (866) 955 -9495 | ||
| Facsimile: (905) 417 - 4422 | ||
| Key Contact: | Louie P. Canitano | |
| President, Solica Inc. | ||
| e-mail: lcanitano@solicacorp.com |
II. Device Description
The LightStream Laser is a handheld, non-invasive, low energy, non thermal infrared therapeutic medical laser. The LightStream Laser System incorporates an AC or battery powered Control Unit and a hand-held laser diode probe with one laser tip and one cluster probe with 5 laser tips. The device incorporate Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering 60mW at the 903 nanometer (nm) wavelength, classifying it under under 21 CFR 890.5500, NHN as non-heating infrared lamp for adjunctive use in pain therapy. The LightStream is a non thermal device and is intended to be for adjunctive use in pain therapy and is not intended to provide therapeutic topical heating.
1
III. Indication for Use
The LightStream Low Level Laser device is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
IV. Predicate Devices
The LightStream Low Level Laser is substantially equivalent to the Theralase Inc. Theralase TLC-100 (K050342. This devices was cleared for introduction into interstate commerce via the FDA's 510(k) Notification process. The LightStream Low Level Laser has the same intended use and similar technological characteristics as the predicate device.
V. Summary of the Technical Characteristics of the Laser System as Related to the Referenced Predicate Devices.
The LightStream Low Level Laser and the predicate device are non-invasive, low energy, non thermal infrared therapeutic medical infrared lasers as defined in 21 CFR 890.5500, under product code NHN. These devices use infrared diodes laser diodes delivering between 5 -500 Mw at the 930 nanometer (nm) wavelength to emit invisible photonic energy to tissue. The LightStream Low Level Laser and the predicate device has the same intended uses and similar technical and performance characteristics.
VI. Testing
Safety and performance testing was performed on the LightStream Low level Laser. The testing has demonstrated that the device complies with both safety and performance FDA recognized consensus standards that apply to the LightStream Low Level Laser. The LightStream Low level Laser has been tested and complies with the following standards:
| General Safety standard: | IEC 60601-1: 2005 |
|---|---|
| EMC | IEC 60601-1-2: 2001 |
| Medical Laser Equipment: | IEC 60601-2-22: 2007 |
| CE Marking Classification: | Medical Device Directive Ilb, Certificate No. |
| C10151 |
2
VII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the LightStream Low Level Laser has the equivalent intended uses and similar technical characteristics as the identified predicate device. The LightStream Low Level Laser complies with FDA consensus and internationally accepted standards for therapeutic lasers intended for adjunctive use in pain therapy. The LightStream Low Level Laser performs as intended, meets the requirements for the 21 CFR 890.5500, under product code NHN and does not raise any new questions of safety or effectiveness.
ﻤﺴﺴﺴ
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" in a circular arrangement.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Solica, Inc. % Ms. Carla Winslow Controller 129 Yorkville Avenue, Suite 300 Toronto, Ontario M5R 1C4 Canada
Re: K081166
APR - 3 2009
Trade/Device Name: LightStream Low Level Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: NHN Dated: March 25, 2009 Received: March 30, 2009
Dear Ms. Winslow:
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. Ilsting 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
4
Page 2 - Ms. Carla Winslow
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.
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
For Math
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
LightStream Low Level Premarket Notification 510(k)
March 25, 2009
Response To Question
K081166
Indications for Use
| 510(k) Number (if known): | K081166 |
|---|---|
| Device Name: | LightStream Low Level Laser |
| Indications for Use: |
The LightStream Low Level Laser device is intended for adjunct use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OROver-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
ongurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041166
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