(57 days)
Not Found
No
The summary describes a standard diode laser device for hair removal and lesion treatment. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The description focuses on the laser's wavelength, pulse characteristics, and user interface.
Yes
The device is indicated for "hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions," which are all therapeutic purposes.
No
The device is indicated for therapeutic purposes (hair removal, permanent hair reduction, treatment of benign vascular and pigmented lesions) and does not describe any function related to diagnosing a condition or disease.
No
The device description explicitly states it is "laser operation equipment" composed of a "main body" and a "hand piece for irradiation of laser," indicating it is a hardware device that emits a laser beam.
Based on the provided information, the Emvera Diolux is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The Emvera Diolux is a laser device that directly interacts with the patient's skin for hair removal and treatment of lesions. It does not analyze biological samples.
- The intended use clearly describes a therapeutic and cosmetic application. The device is used to treat conditions on the body, not to diagnose or monitor a patient's health through laboratory analysis.
- The device description details a laser operation equipment. This is consistent with a device used for physical treatment, not for in vitro testing.
Therefore, the Emvera Diolux falls under the category of a therapeutic or cosmetic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Emvera Diolux is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Hair removal by laser or IPL sources can cause increase hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
This laser operation equipment is a diode laser of 808nm of pulsed diode laser.
This equipment is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to be use in various treatments by effecting the skin by laser beam of 808nm.
Diode laser of 808nm is able to transfer stable and uniform pulses to skin, therefore operator can treat patient safely and effectively using this equipment. This equipment provides direct visual color LCD screen configured with prompts for ease of use for the operator.
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
By or on the order of a physician.
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): 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
Summary Preparation Date:
August 23, 2011
123257
Company:
Emvera Technologies, LLC. 641 10th Street Cedartown, GA 30125
Contact Information:
770-749-1530 Phone: Fax: 888-361-7636
Contact Person:
Lyle Fuller
Device Name: Common/Usual Name: Classification Name: Requlation Number: Product Code: Device Class: Review Panel:
Emvera Diolux Surgical Laser Powered Laser Surgical Instrument 21 CFR 878.4810 GEX Class II Division of General, Restorative and Neurological Devices
Predicate Device:
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Willia
1 4000 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Company of Concession College of Concession Company of Concession Company of Children Company of Children Company of Children Company of Children Company of Children Company
Company of Canada Company of Children Company of Children Company of Children Company Come of Children Company of Children Company of Children Company of Children Company Com | onrano | 1400740 |
Device Description
This laser operation equipment is a diode laser of 808nm of pulsed diode laser.
This equipment is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to be use in various treatments by effecting the skin by laser beam of 808nm.
Diode laser of 808nm is able to transfer stable and uniform pulses to skin, therefore operator can treat patient safely and effectively using this equipment. This equipment provides direct visual color LCD screen configured with prompts for ease of use for the operator.
Indications for Use
The Emvera Diolux is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.
1
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Hair removal by laser or IPL sources can cause increase hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.
Caution: Federal (USA) law restricts this device for use by or on the order of a physician.
Safety Testing
Electrical Safety Testing and Biocompatibility requirements have been met.
| Parameters | Emvera Diolux | Alma Lasers, Inc.
Soprano XL |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K102716 |
| Indications for Use | The Emvera Diolux is
indicated for hair
removal, permanent hair
reduction and for the
treatment of benign
vascular and pigmented
lesions. | The Diode Laser Module:
The HR Mode is intended
for hair removal,
permanent hair reduction.
The LaserBlanche Mode
is intended for the
treatment of benign
vascular and pigmented
lesions. |
| Laser Type | Laser Diode | AlGaAs Diode / CW |
| Wave Length | 808nm | 800nm |
| Fleunce | Up to 120 J/cm² | Up to 120 J/cm² |
| Mode | Pulsed | Pulsed |
| Duration | 5-625 ms | 10-1,350 ms |
| Repetition | 1-2 Hz DP 2
1-3 Hz DP 1
5-10 Hz FDP Mode | 1-3 Hz Pulse Mode
1-10 Hz SHR Mode |
| Spot Size | 12.0 mm (Square) | 12 x 10 mm (Square) |
| Cooling | Water Cooling | Dual Chill |
| Weight | 26 Kg | 27 Kg |
| Power Input | 120/230V 20/10 A 50/60
Hz | 120/230V 20/10 A 50/60
Hz |
Predicate Product Comparison
Based on the comparisons found in the predicate product comparison table no new issues of safety and effectiveness are raised in this original new 510(k).
2
This conclusion is based on the fact that the Emvera Diolux and the Alma Lasers Soprano XL have the same as or similar product characteristics, such as laser type, wave length, flounce, mode, duration, repetition, spot size, cooling and power input.
.
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 with three overlapping wings, representing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: December 14, 2012
Emvera Technologies, Incorporated % Smith Associates Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook, Illinois 60062
Re: K123257
Trade/Device Name: Emvera Diolux Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX
Dated: October 16, 2012 Received: October 18, 2012
Dear Mr. Devine:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Mr. Ned Devine
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
Indications for Use
510(k) Number K123257
Emvera Diolux
Indications for Use:
The Emvera Diolux is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Hair removal by laser or IPL sources can cause increase hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.
Caution: Federal (USA) law restricts this device for use by or on the order of a physician.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Neil R Ogden 2012.12.04 ¸09:05:08 -05'00'
(Division Sign-off) for MXM Division of Surgical Devices 510(k) Number
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