(192 days)
Not Found
No
The summary describes a standard diode laser device for aesthetic treatments and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for treating specific medical conditions (benign superficial vascular and benign superficial pigmented lesions) and providing permanent hair reduction, which are therapeutic interventions affecting the body.
No
The device is indicated for hair removal, permanent hair reduction, and the treatment of benign superficial vascular and pigmented lesions. These are therapeutic and aesthetic purposes, not diagnostic.
No
The device description explicitly states it is a "diode laser of 808nm system" 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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal, permanent hair reduction, and treatment of benign superficial vascular and pigmented lesions. These are all procedures performed directly on the patient's body (in vivo).
- Device Description: The device is a laser system designed to irradiate the skin with a laser beam. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's health condition. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the ELux810 Laser is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ELux810 Laser is indicated for hair removal, permanent hair reduction in people with Fitzpatrick skin type I-V. It is also indicated for the treatment of benign superficial vascular and benign superficial pigmented lesions in people with Fitzpatrick skin type I-IV. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
Product codes
GEX
Device Description
The ELux810 Laser is a diode laser of 808nm system. This device is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to use in various treatments by effecting to skin by laser beam of 808nm generated from laser diode. Diode laser of CW system is able to transfer stable and uniform pulses to skin, therefore medical doctor can treat patient safely and effectively using this equipment.
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
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 ELux810 Laser met the appropriate requirements contained in the following FDA Guidance Documents, Regulations and Standards:
US FDA Guidance Documents: Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (Draft), June 1995
US Regulations: 21CFR Part 1040, Sections 1040.10 and 1040.11 with permissible deviations relative to Laser Notice 50, dated June 24, 2007.
Recognized Consensus Standards:
- ISO 14971, Second Edition, 2007-03-01, Medical Devices Application of -Risk Management to Medical Device.
- IEC 60601-1: 2005 (Third Edition) Medical electrical equipment Part 1: -General requirements for basic safety and essential performance and tested for compliance with all functional requirements,
- EN 60601-1-2: 2007, Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- -EN 60601-1-6: 2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- -IEC 60601-2-22: 2007 (Third Edition), Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment,
- IEC 60825-1:2007 Safety of Laser Products Part 1: Equipment classification, requirements and user's guide,
- IEC 62304:2006, Medical device software Software life cycle processes, -
- IEC 62366-1:2008 Medical Devices Application of usability engineering to medical devices
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, with flowing lines representing hair or movement. The profiles are arranged in a staggered formation, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2015
EquipMed North America Incorporated Mr. Jim Barley Director of Regulatory Affairs 411 Lucerne Drive #1 Verona, Wisconsin 53593
Re: K141986 Trade/Device Name: ELux810 Medical Laser 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: December 19, 2014 Received: December 24, 2014
Dear Mr. Barley:
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 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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours. Jennifer R. Stevenson -A Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141986
Device Name
ELux810 Medical Laser
Indications for Use (Describe)
The ELux810 Laser is indicated for hair removal, permanent hair reduction in people with Fitzpatrick skin type I-V. It is also indicated for the treatment of benign superficial vascular and benign superficial pigmented lesions in people with Fitzpatrick skin type I-IV. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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FORM FDA 3881 (8/14)
Page 1 of 1
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
P
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510(k) Summary
(As required by 21 CFR 807.92(a))
Summary of Safety and Effectiveness for the ELux810 Medical Laser
Date Prepared: January 27, 2015
- A. Submitter Information
| EquipMed North America, Inc. | |
|---|---|
| 411 Lucerne Drive # 1 | |
| Verona, WI 53593 | |
| Contact: | Stene Marshall |
| Phone Number: | 954-643-2510 |
| Trade Name: | ELux810 Medical Laser |
B. Device Information
| Trade/Proprietary Name: | ELux810 Medical Laser |
|---|---|
| Common name of device: | Semi-Conduct Laser unit |
| Classification Name: | Powered Laser Surgical Instrument |
| Product Code: | 78 GEX |
| Regulatory Class: | II |
| Classification Number: | 878.4810 |
| Reason for 510(k): | New device |
C. Primary Predicate Device:
| Predicate 510(k) #: | K123257 |
|---|---|
| Predicate product code: | GEX |
- D. Device Description
The ELux810 Laser is a diode laser of 808nm system. This device is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to use in various treatments by effecting to skin by laser beam of 808nm generated from laser diode. Diode laser of CW system is able to transfer stable and uniform pulses to skin, therefore medical doctor can treat patient safely and effectively using this equipment.
4
-
E. Statement of Indications for Use
The ELux810 Laser is indicated for hair removal, permanent hair reduction in people with Fitzpatrick skin type I-IV. It is also indicated for the treatment of benign superficial vascular and benign superficial pigmented lesions in people with Fitzpatrick skin type I-IV. Permanent hair reduction is defined as the longterm, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. -
F. Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the ELux810 Laser, Emvera Diolux Laser (Primary Predicate Device). The following comparison chart shows that the subject device and the predicate device are substantially equivalent:
| Parameters | ELux810 Laser | Emvera Diolux Laser | Determination |
|---|---|---|---|
| Indications for Use | The ELux810 Laser is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions. | The Emvera Diolux Laser is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions. | Same |
| Principal of Operation | The laser beams a highly concentrated light into hair follicles. The pigment in the hair follicle absorbs the light which destroys the hair. | The laser beams a highly concentrated light into hair follicles. The pigment in the hair follicle absorbs the light which destroys the hair. | Same |
5
| Parameters | ELux810 Laser | Emvera Diolux
Laser | Determination |
|------------------------------------------|------------------------------------------------|---------------------------------------------------|----------------|
| Light Source | Diode (Continuous
Wave) | Diode (Continuous
Wave) | Same |
| Wave Length | 808 nm | 808nm | Same |
| Laser Diode
Power | Max 600w | Max 600w | |
| Energy
Density/Fleunce | Up to 120J/cm2 | Up to 120J/cm2 | Same |
| Mode | Pulsed | Pulsed | Same |
| Pulse Duration | 5-625ms | 5-625ms | SE |
| Pulse Repetition
Rate
(Repetition) | 1-2 Hz DP 2
1-6 Hz DP 1
5-10 Hz FDP Mode | 1-2 Hz DP 2
1-3 Hz DP 1
5-10 Hz FDP
Mode | SE |
| | Spot Size | 12 x 11 mm | 12 mm (Square) |
| Cooling | Water Cooling (-
5°C5°C) | Water Cooling (-5°C) | SE |
5°C
| Optical Guide | Sapphire Crystal | Sapphire Crystal | Same |
| Power Input | 120/230V 20/10 A
50/60 Hz | 120/230V 20/10 A
50/60 Hz | |
- G. Summary and Conclusion of Nonclinical and Clinical Tests:
The ELux810 Laser met the appropriate requirements contained in the following FDA Guidance Documents, Regulations and Standards:
US FDA Guidance Documents
Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (Draft), June 1995
US Regulations
21CFR Part 1040, Sections 1040.10 and 1040.11 with permissible deviations relative to Laser Notice 50, dated June 24, 2007.
6
Recognized Consensus Standards
- ISO 14971, Second Edition, 2007-03-01, Medical Devices Application of -Risk Management to Medical Device.
- IEC 60601-1: 2005 (Third Edition) Medical electrical equipment Part 1: -General requirements for basic safety and essential performance and tested for compliance with all functional requirements,
- EN 60601-1-2: 2007, Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- -EN 60601-1-6: 2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- -IEC 60601-2-22: 2007 (Third Edition), Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment,
- IEC 60825-1:2007 Safety of Laser Products Part 1: Equipment classification, requirements and user's guide,
- IEC 62304:2006, Medical device software Software life cycle processes, -
- IEC 62366-1:2008 Medical Devices Application of usability engineering to medical devices
H. Discussion of Clinical Tests:
None submitted
I. Conclusions Demonstrating Safety, Effectiveness and Performance:
The ELux810 Laser has been tested and found to meet all product specifications and requirements. The device was tested to all of the appropriate FDA regulations and Consensus Standards and met all requirements. The device labeling met all FDA requirements and the device has the appropriate safety warning labels.
After review of the Risk Analysis, all verification and validation test data and reports, the conclusion of the Design Review Committee was that the ELux810 Laser is safe and effective for its intended use and is substantially equivalent to the predicate device.