(189 days)
Not Found
No
The device description focuses on the physical components and technical specifications of the laser system, with no mention of AI or ML capabilities. The performance studies described are related to safety and compatibility, not algorithmic performance.
Yes
The device description and intended use explicitly state that the Laser-D68 System provides therapy for various physical ailments, indicating its therapeutic purpose.
No
The device is described as a "low energy infrared therapeutic medical laser" intended to perform "laser therapy" for the relief of various aches, pains, stiffness, and muscle conditions. There is no mention of it being used to diagnose conditions or collect diagnostic data.
No
The device description clearly outlines hardware components including a driver unit and three different laser probes, indicating it is a physical medical device, not software-only.
Based on the provided information, the Laser-D68 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic device that applies laser energy to the body for topical heating and relief of pain, stiffness, and muscle issues. This is a direct treatment applied to a living organism.
- Device Description: The description details a laser system with probes that emit light for therapeutic purposes. It does not mention any components or processes related to examining specimens taken from the body (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in samples, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Laser-D68 System's function is entirely external and therapeutic.
N/A
Intended Use / Indications for Use
Laser-D68 System provides visible red and infrared therapy to provide topical heating for the temporary:
- Increase in local blood circulation
- Relief of minor muscles and joint aches, pains and stiffness .
- Relaxation of muscles
- . Relief of muscle spasms
- . Relief of minor pain and stiffness associated with arthritis
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The Laser-D68 is a non-invasive, low energy infrared therapeutic medical laser that is intended to perform laser therapy in healthcare centers, physical therapy laboratories, and family doctor practices.
The Laser D68 is supplied with three different probes that are used to generate, laser radiation when connected to the D68 driver unit. Probe #1 is a 660nm, Indium Gallium Aluminum Phoshpide (InGaAIP) laser diode (visible red light) with an adjustable treatment power output from 1 milliwatts (mW) to 50 milliwatts (mW) (in 1mW increments). Probe #2 is an 830nm, Gallium Aluminum Arsenide (GaAIAs) Iaser diode (infrared light) with an adjustable treatment power output from 20 milliwatts to 400 milliwatts (in 5mW increments). Probe #3 is a 904nm, Gallium Arsenide (GaAs) laser diode (infrared light) with adjustable treatment power output of either SmW to 90mW (in 5mW increments) (45W laser power source) or 5 mW to 150mW (in 5 mW increment) (75W modulated laser power source).
Each of the laser probes are fully interchangeable with the D68 driver.
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
healthcare centers, physical therapy laboratories, and family doctor practices.
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)
Testing of the Laser-D68 included electrical safety testing, laser safety testing and electromagnetic compatibility testing. The Laser-D68 meets the applicable requirements of CFR 1040. The Laser-D68, as with the predicate devices, has been certified to the requirements of the Medical Devices Directive 93/42/EEC, and is CE Marked
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
KO6/656
510(k) Summary (per 21 CFR 807.92)
DEC 1 5 2006
I. Applicant Laser Pain Clinics 300 N Highland, Suite 105 WNJ Medical Office Building Sherman, Texas 75092
| Contact Person: | Holly Wright, Manager and President
LaserMD Management GP, LLC (General Partner)
c/o LaserMD Management GP, LLC
903.868.1350 telephone
206.203.2001 Facsimile
e-mail: holly.wright@laserpainclinics.com |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | November 6, 2006 |
II. Device Name
| Proprietary Name: | Laser-D68 |
|---|---|
| Common/ Usual Name: | Infrared Lamp |
| Classification Name: | Lamp, infrared, therapeutic heating |
| Regulation Number: | 890.5500 |
| Product Codes: | ILY |
| Classification: | 2 |
| Classification Panel: | Physical Medicine |
III. Predicate Device
Laser Pain Clinics is substantially equivalent to the Eltech s.r.l K-Laser (K050070) and the Advanced Medical Technologies Maestro MDTTL Laser System (K053473). The devices are therapeutic medical lasers designed to deliver light energy to the target tissue.
IV. Intended Use of the Device
Laser-D68 System provides visible red and infrared therapy to provide topical heating for the temporary:
- Increase in local blood circulation �
- Relief of minor muscles and joint aches, pains and stiffness .
- Relaxation of muscles .
- . Relief of muscle spasms
- . Relief of minor pain and stiffness associated with arthritis
V. Description of the Device
The Laser-D68 is a non-invasive, low energy infrared therapeutic medical laser that is intended to perform laser therapy in healthcare centers, physical therapy laboratories, and family doctor practices.
Page 5-1
1
The Laser D68 is supplied with three different probes that are used to generate, laser radiation when connected to the D68 driver unit. Probe #1 is a 660nm, Indium Gallium Aluminum Phoshpide (InGaAIP) laser diode (visible red light) with an adjustable treatment power output from 1 milliwatts (mW) to 50 milliwatts (mW) (in 1mW increments). Probe #2 is an 830nm, Gallium Aluminum Arsenide (GaAIAs) Iaser diode (infrared light) with an adjustable treatment power output from 20 milliwatts to 400 milliwatts (in 5mW increments). Probe #3 is a 904nm, Gallium Arsenide (GaAs) laser diode (infrared light) with adjustable treatment power output of either SmW to 90mW (in 5mW increments) (45W laser power source) or 5 mW to 150mW (in 5 mW increment) (75W modulated laser power source).
Each of the laser probes are fully interchangeable with the D68 driver.
Summary of the Technical Characteristics for the Laser-D68 to the VI. referenced predicate devices.
The Laser-D68 and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices use infrared diodes to emit invisible photonic energy to tissue. The intended use is identical for all devices.
VII. Testing
The testing of the Laser-D68 included electrical safety testing, laser safety testing and electromagnetic compatibility testing.
Safety & Effectiveness VIII.
There are no substantial differences between the Laser-D68 defined in this 510(k) submission and the predicate devices. They are similar to the technologies that are currently used in other similar medical devices.
The Laser-D68 included electrical safety testing, laser safety testing and electromagnetic compatibility testing.
The Laser-D68 meets the applicable requirements of CFR 1040.
The Laser-D68, as with the predicate devices, has been certified to the requirements of the Medical Devices Directive 93/42/EEC, and is CE Marked
2
Image /page/2/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 symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Laser Pain Clinics % Ms. Holly Wright Manager and President 300 N. Highland, Suite 105 Sherman, Texas 75092
DEC 1 5 2006
Re: K061656
Trade/Device Name: Laser D-68 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: November 6, 2006 Received: November 7, 2006
Dear Ms. Wright:
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.
3
Page 2 - Ms. Holly Wright
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
LASER
PAIN CLINICS
4. Indication for Use Statement
510(k) Number (if known): K061656
Device Name: Laser D-68
Indications for Use:
Laser-D68 System provides visible red and infrared therapy to provide topical heating for the temporary:
- Increase in local blood circulation ●
- Relief of minor muscles and joint aches, pains and stiffness .
- Relaxation of muscles
- Relief of muscle spasms
- Relief of minor pain and stiffness associated with arthritis
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)
(Division Sign-Off)
Division of General Restorative,
and Neurological Devices
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| 510(k) Number | K061656 |
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| K061656 MNM |