(150 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on laser technology without mentioning any AI/ML components or functionalities.
Yes
The device is indicated for "adjunctive use in the temporary relief of pain associated with knee disorders," which directly addresses a medical condition, making it a therapeutic device.
No
The device is indicated for "adjunctive use in the temporary relief of pain associated with knee disorders," which describes a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "hand held portable multiple laser probe" and a "laser controller unit with a rechargeable battery," indicating it includes physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with knee disorders. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a therapeutic medical laser system that applies light to the body. It does not involve testing samples of human origin (like blood, urine, or tissue) outside of the body, which is the core characteristic of an IVD.
- Performance Studies: The performance studies evaluate the device's effectiveness in reducing pain, not its ability to diagnose a condition or measure a substance in a biological sample.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used to treat a condition directly on the body.
N/A
Intended Use / Indications for Use
The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
Product codes
NHN
Device Description
The Theralase™ TLC-1000 Therapeutic Medical Laser System is a non-heating infrared lamp as defined in 21 CFR 890.5500. The TLC-1000 system is a precision medical device as wontion of a hand held portable multiple laser probe (5 x 905 NIR laser diodes and 4 x 660 visible red laser diodes) and a laser controller unit with a rechargeable battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
19 years and older.
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 Theralase™ TLC-1000 Therapeutic Medical Laser System was evaluated in a prospective, single blind, randomized controlled study that compared the "Active" Laser with a Sham Laser. The multi center study included a total of 122 adult male and female subjects conducted at three investigational sites in the United States of America.
Clinical Data Analysis and Results:
Statistical analyses were performed by generally accepted statistical techniques to evaluate the differences between the VAS scores from pre-treatment to post-treatment in Group A (Active Laser) and Group B (Sham Laser).
The statistical analyses of the data demonstrate that the difference between the two treatment groups was statistically significant (p-value
§ 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
KOSO342
JUL 1 1 2005
SUMMARY OF SAFETY AND EFFICACY
Theralase™ Inc.
TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
April 215t, 2005
GENERAL INFORMATION l.
| Device Generic Name: | TLC-1000 |
|---|---|
| Trade Name: | Theralase TLC-1000 Therapeutic Medical Laser System |
| Device Classification: | Class 2, Performance Standards |
| 21 CFR Part 890.5500 - Infrared Lamp, Non-Heating | |
| Product Code: | NHN |
| Applicant Name and Address: | Theralase Inc. |
| 600 Alden Road, Suite 101 | |
| Markham, Ontario | |
| L3R 0E7, CANADA | |
| Phone: [1]-905-947-8455 | |
| Fax: [1]-905-947-8550 | |
| 510(k) Number: | K050342 |
DEVICE DESCRIPTION II.
The Theralase™ TLC-1000 Therapeutic Medical Laser System is a non-heating infrared lamp as defined in 21 CFR 890.5500. The TLC-1000 system is a precision medical device as wontion of a hand held portable multiple laser probe (5 x 905 NIR laser diodes and 4 x 660 visible red laser diodes) and a laser controller unit with a rechargeable battery.
INDICATIONS FOR USE lll.
The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
ALTERNATIVE PROCEDURES OR PRACTICES IV.
The primary alternatives for use in treating chronic or acute knee pain include the use of TENS, steroids, non-steroidal anti-inflammatory drugs (NSAIDS) and barbiturated drugs (known to be addictive and relatively toxic).
1
SUMMARY OF CLINICAL STUDIES V.
The Theralase™ TLC-1000 Therapeutic Medical Laser System was evaluated in a The Theralase - TLC-1000 Therapeatio Modical tudy that compared the "Active" Laser with prospective, single billid, fandomized ochtronical ducted at three investigational sites in the a Shaff Laser. The multi ochor study included a total of 122 adult male and female subjects Offited States of Amentod. The Stady the following conditions were met: diagnosis of To years and older. Enfoliment oooured in the followith a pain level of at least 4 as measured Knee pain ulsolder, modelate to severe symptomating while and failed conservative therapy by a f ain Ecver Abousement who had not had previous knee surgery.
Clinical Data Analysis and Results
Statistical analyses were performed by generally accepted statistical techniques to evaluate Statistical analyses were performed by gonomiry desepted and prethe differences between the VAO soorco from pro treatingts in Group A (Active Laser) and Group B (Sham Laser).
The statistical analyses of the data demonstrate that the difference between the two TTIe Statistical analyses of the Gata demonomount.o the unt (p-value