(48 days)
Not Found
Not Found
No
The 510(k) summary describes a laser device for pain relief and acne treatment and contains no mention of AI or ML technology.
Yes
The device is indicated for providing temporary relief of pain and treating dermatological conditions, which are therapeutic uses.
No
The device is indicated for providing temporary relief of pain and treating dermatological conditions, which are therapeutic uses, not diagnostic.
No
The device description explicitly states "Erchonia EVRL Laser," indicating a hardware device that emits laser light. The intended use also describes the use of "red diode" and "blue diode," which are hardware components of a laser.
Based on the provided information, the Erchonia EVRL Laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device being applied externally to the body (neck and shoulder, skin) for therapeutic purposes (pain relief, treating acne). IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health.
- Device Description: The description is for a laser, which is a physical therapy or dermatological device, not a device designed for analyzing biological samples.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
Therefore, the Erchonia EVRL Laser, as described, falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Erchonia EVRL Laser is generally indicated:
- while using the red diode, for adjunctive use in providing temporary relief of a. minor chronic neck and shoulder pain of musculoskeletal origin, and
- b. while using the blue diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neck and shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked vertically.
MAY - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Erchonia Medical, Inc. C/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127
Re: K050672
Trade/Device Name: Erchonia EVRL Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: April 13, 2005 Received: April 14, 2005
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreate) to the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, are cance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Costicule Hot (110-) that to novice, subject to the general controls provisions of the Act. The 1 ou may, mercrore, mailies of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is classified (discuss controls. Existing major regulations affecting your device it may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oououncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualite or woulder with other requirements of the Act that I DA has made a dolorimistered by other Federal agencies. You must or any rederal statutes and regulations and inding, but not limited to: registration and listing (2 l comply with an the Act 31equirements) 11 CFR Part 801); good manufacturing practice requirements as set CFR Fart 807), adeling (21 CFR Part 820); and If applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kevin Walls, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to ogin manetally your antial equivalence of your device to a legally premits in the 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 If you desire specific advice for your ac note the regulation of the regulation entitled, Colliact the Office of Compulation in (21CFR Part 807.97). You may obtain Misolanding by release to promanto no nomanto new the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
2
Indications for Use
510(k) Number (if known): K050672
Device Name: Erchonia EVRL Laser
Indications for Use: The Erchonia EVRL Laser is generally indicated:
- while using the red diode, for adjunctive use in providing temporary relief of a. minor chronic neck and shoulder pain of musculoskeletal origin, and
- b. while using the blue diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
ﯿﮟ
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restorative
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