(46 days)
Not Found
No
The summary describes a light-based therapy device with no mention of AI or ML components or functions.
Yes
The device is indicated for the treatment of wrinkles, rhytids, and fine lines in the periorbital region, which are medical conditions, and thus the device provides a therapeutic benefit.
No
Explanation: The device is indicated for treatment of wrinkles, rhytids, and fine lines, and its description focuses on light delivery for therapeutic purposes, rather than detecting or identifying a medical condition.
No
The device description explicitly details hardware components such as a base, articulated arm, treatment head, power supply, controller, ventilation system, LED-based optics, and positioning system.
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 "treatment of wrinkles, rhytids and fine lines in the periorbital region." This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device delivers visible light for treatment. It does not involve the analysis of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, the LumiPhase-R is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LumiPhase-R ™ is indicated for treatment of wrinkles, rhytids and fine lines in the periorbital region.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The LumiPhase-R system delivers visible light at a wavelength of 660 nanometers. This LED device consists of three interconnected sections: the base which houses the power supply, the articulated arm and the treatment head consisting of the controller, the ventilation (heat sink) system, the LED based optics and the positioning system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital region
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)
Clinical studies were conducted to provide assurance that the performance of the device is equivalent to the predicate devices. Results were acceptable and did not raise any new issues of safety and effectiveness.
Nonclinical Performance: The LumiPhase-R was tested and complies with IEC 60825-1 Laser Safety Testing. The LumiPhase-R will comply with IEC 60601-1-2 and CAN/CSA c22.2, No. 601.1-M90. In vitro testing and bench testing was performed and determined to be acceptable. Based upon an analysis of the overall performance characteristics for the device, Opusmed Inc. believes that no significant differences exist. Therefore, the LumiPhase-R raises no new issues of safety or effectiveness.
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
510(k) Summary of Safety and Effectiveness
051255
Opusmed Inc. LumiPhase-R™
JUL 0 1 2005
| 510(k)
Summary | This summary of 510(k) safety and effectiveness information is
being submitted in accordance with the requirements of 21 C.F.R.
§ 807.92. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission
Correspondant: | Emergo Group Inc.
2454 McMullen Booth Road, Suite 427
Clearwater, FL 33759 USA |
| Phone: | 727-797-4727 |
| Fax: | 727-797-4757 |
| Contact: | Mr. Ian Gordon |
| e-mail: | igordon@emergogroup.com |
| Submission
Sponsor: | Opusmed Inc.
3333 Graham Boulevard, Suite 306
Mount-Royal, (Quebec) H3R 3L5
Canada |
| Date Prepared | May 6, 2005 |
| Name of device | LumiPhase-R™ |
| Classification
Names | Laser surgical instrument for use in general and plastic
surgery and in dermatology |
| Device
Classification | Regulatory Class: II
Product Code: GEX
Classification Panels: General & Plastic Surgery
Regulation Number: 21 C.F.R. 878.4810 |
1
s1255
| 510(k) Summary of Safety and Effectiveness |
|---|
| -------------------------------------------- |
.
.
100 - 100 -
:
| Opusmed Inc.
| LumiPhase-R™ | |
|---|---|
| ------------------------------ | -- |
Predicate Device(s)
| 510(k)# | Device | Manufacturer |
|---|---|---|
| K030426 | Omnilux Revive | Photo Therapeutics Limited |
| K031425 | GentleWaves LED Photomodulation Device | Light BioScience L.L.C. |
Device Description
The LumiPhase-R system delivers visible light at a wavelength of 660 nanometers. This LED device consists of three interconnected sections: the base which houses the power supply, the articulated arm and the treatment head consisting of the controller, the ventilation (heat sink) system, the LED based optics and the positioning system.
Indications
The LumiPhase-R ™ is indicated for treatment of wrinkles, rhytids and fine lines in the periorbital region.
Nonclinical Performance
The LumiPhase-R was tested and complies with IEC 60825-1 Laser Safety Testing. The LumiPhase-R will comply with IEC 60601-1-2 and CAN/CSA c22.2, No. 601.1-M90.
In vitro testing and bench testing was performed and determined to be acceptable. Based upon an analysis of the overall performance characteristics for the device, Opusmed Inc. believes that no significant differences exist. Therefore, the LumiPhase-R raises no new issues of safety or effectiveness.
Page 2
2
Opusmed Inc. LumiPhase-R™ Clinical Performance Clinical studies were conducted to provide assurance that the performance of the device is equivalent to the predicate devices. Results were acceptable and did not raise any new issues of safety and effectiveness. Conclusion By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics. But, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device. The differences between the Opusmed LuminPhase-R and the predicate devices cited do not raise any different questions regarding safety and effectiveness. The LumiPhase-R device, as designed, is as safe and effective as the predicate devices, and the device is determined to be substantially equivalent to the referenced predicate devices.
Koj 1255
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure with outstretched arms, suggesting care and protection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Opusmed Incorporated C/o Mr. Ian Gordon Emergo Group Incorporated 2454 McMullen Booth Road, Suite 427 Clearwater, Florida 33759
JUL 0 1 2005
Re: K051255
Trade/Device Name: LumiPhase-RTM Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 9, 2005 Received: May 18, 2005
Dear Mr. Gordon:
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 iffecting 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.
4
Page 2- Mr. Ian Gordon
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,
Signature
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
Image /page/4/Picture/7 description: The image shows a black and white graphic with a sparse distribution of black shapes against a white background. The shapes vary in size and form, with some appearing as small clusters and others as isolated marks. The overall impression is one of scattered elements with no clear pattern or structure.
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INDICATIONS FOR USE
K051255 510(k) Number (if known):
LumiPhase-R ™ Device Name:
Indications for Use:
The LumiPhase-R ™ is indicated for treatment of wrinkles, rhytids and fine lines in the periorbital region.
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)
Division Sign-Off) Division of General, Restorative ്
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