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.

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.

AI/ML Overview

This document (K141986) is a 510(k) premarket notification for the ELux810 Medical Laser. It primarily focuses on demonstrating substantial equivalence to a predicate device (Emvera Diolux Laser) rather than providing detailed clinical study results with acceptance criteria in the typical sense of an AI/ML device performance study.

Therefore, the specific information requested in your prompt (e.g., sample sizes for test sets, number of experts, adjudication methods for ground truth, MRMC studies, standalone performance, training set details) is not present in this document. This document describes a medical device (a laser) and its technical specifications, and the regulatory approval process relies on demonstrating that this new device is fundamentally similar and performs comparably to an already legally marketed device with established safety and effectiveness.

Here's a breakdown of what can be extracted regarding "acceptance criteria" and "device performance" in the context of this 510(k), along with an explanation of why other requested details are not applicable:

1. A table of acceptance criteria and the reported device performance

In the context of this 510(k), "acceptance criteria" are essentially met by demonstrating that the ELux810 Laser's characteristics and performance are "substantially equivalent" to the predicate device, Emvera Diolux Laser. The performance is assessed by comparing technical specifications and ensuring adherence to recognized standards for laser devices.

Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate)	ELux810 Medical Laser Reported Performance (Specifications)
Indications for Use: Same as predicate	Hair removal, permanent hair reduction (Fitzpatrick skin type I-V); treatment of benign superficial vascular and benign superficial pigmented lesions (Fitzpatrick skin type I-IV).
Principal of Operation: Same as predicate	Laser beams highly concentrated light into hair follicles; pigment absorbs light, destroying hair.
Light Source: Same as predicate	Diode (Continuous Wave)
Wave Length: Same as predicate	808 nm
Laser Diode Power: Max 600w (Same as predicate)	Max 600w
Energy Density/Fluence: Up to 120J/cm2 (Same as predicate)	Up to 120J/cm2
Mode: Pulsed (Same as predicate)	Pulsed
Pulse Duration: 5-625ms (SE to predicate)	5-625ms
Pulse Repetition Rate (Repetition): 1-2 Hz DP 2, 1-6 Hz DP 1, 5-10 Hz FDP Mode (SE to predicate)	1-2 Hz DP 2, 1-6 Hz DP 1, 5-10 Hz FDP Mode
Spot Size: 12 x 11 mm (SE to predicate)	12 x 11 mm
Cooling: Water Cooling (-5°C~5°C) (SE to predicate)	Water Cooling (-5°C~5°C)
Optical Guide: Sapphire Crystal (Same as predicate)	Sapphire Crystal
Power Input: 120/230V 20/10 A 50/60 Hz (Same as predicate)	120/230V 20/10 A 50/60 Hz
Met US FDA Guidance Documents	Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (Draft), June 1995
Met US Regulations	21CFR Part 1040, Sections 1040.10 and 1040.11 with permissible deviations relative to Laser Notice 50, dated June 24, 2007.
Met Recognized Consensus Standards	ISO 14971, IEC 60601-1, EN 60601-1-2, EN 60601-1-6, IEC 60601-2-22, IEC 60825-1, IEC 62304, IEC 62366-1

Explanation for "SE" (Substantially Equivalent) in the table: In the context of a 510(k), "SE" means the characteristic is sufficiently similar to the predicate that it does not raise new questions of safety or effectiveness. The slight differences in spot size and pulse repetition rates are considered minor and don't alter the fundamental safety or efficacy profile compared to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this 510(k) submission. This document states "None submitted" for clinical tests (H. Discussion of Clinical Tests). The approval is based on demonstrating substantial equivalence through technical comparison and adherence to safety standards, not a new clinical study with a test set of patient data from an AI/ML context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical test set was submitted, there was no need for experts to establish ground truth in this manner.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication was submitted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser surgical instrument, not an AI/ML diagnostic or assistive device for human readers. No MRMC study was conducted or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical laser, not a software algorithm. Its performance is inherent to its physical operation and specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not directly applicable in the AI/ML sense. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (Emvera Diolux Laser) and the general scientific understanding of how 808nm diode lasers function for the stated indications. The ELux810 is assumed to have similar safety and effectiveness because its technical characteristics are substantially equivalent. The definition of "Permanent hair reduction" (long-term, stable reduction at 6, 9, 12 months) serves as an outcome measure, but it's a definition for the indication, not a ground truth used in a study reported here to validate new AI performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set for an AI/ML algorithm was used.

In summary, this 510(k) submission for the ELux810 Medical Laser establishes its acceptance and suitability for market based on:

Substantial equivalence of its technical specifications and intended use to a legally marketed predicate device.
Compliance with recognized safety and performance standards for medical lasers (e.g., ISO, IEC, EN standards).
Adherence to relevant FDA regulations and guidance documents.

The provided document explicitly states "None submitted" for clinical tests, which is why the detailed information about clinical study design, ground truth, and reader performance you requested for AI/ML devices is not found here.

Summary

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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

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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

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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)

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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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.

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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

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Parameters	ELux810 Laser	Emvera DioluxLaser	Determination
Light Source	Diode (ContinuousWave)	Diode (ContinuousWave)	Same
Wave Length	808 nm	808nm	Same
Laser DiodePower	Max 600w	Max 600w
EnergyDensity/Fleunce	Up to 120J/cm2	Up to 120J/cm2	Same
Mode	Pulsed	Pulsed	Same
Pulse Duration	5-625ms	5-625ms	SE
Pulse RepetitionRate(Repetition)	1-2 Hz DP 21-6 Hz DP 15-10 Hz FDP Mode	1-2 Hz DP 21-3 Hz DP 15-10 Hz FDPMode	SE
	Spot Size	12 x 11 mm	12 mm (Square)
Cooling	Water Cooling (-5°C~5°C)	Water Cooling (-5°C~5°C)	SE
Optical Guide	Sapphire Crystal	Sapphire Crystal	Same
Power Input	120/230V 20/10 A50/60 Hz	120/230V 20/10 A50/60 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.

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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.

Regulation Number and Section

§ 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.