The GME LinScan System with the applicators LinScan 808 and LinScan 980 is indicated for hair removal and permanent hair reduction defined as the stable, long term reduction in hair counts at 6, 9,or 12 months following a treatment regime.

Device Description

The LinScan is a diode laser system designed to be used in Dermatological practice for stable, long term hair reduction. The LinScan System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button), which controls an applicator unit. The applicator unit contains the diode laser and scanner. The unit comes in two models: the LinScan 808 has an applicator with a 808 nm diode laser. The LinScan 980 has an applicator with a 980 nm diode laser. The LinScan System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the LinScan System. Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.

AI/ML Overview

The provided document, K141063 does not contain information on testing results that demonstrate the device meets acceptance criteria. The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Key observations:

No Acceptance Criteria Table: The document does not include a table outlining specific acceptance criteria for device performance.
No Reported Device Performance: While the document lists device specifications (e.g., fluence, pulse widths, wavelength), it does not present performance data from a study to show how the device actually performed against any predefined acceptance criteria.
Focus on Substantial Equivalence: The "Performance Data" section ([4] K141063, H. Performance Data) exclusively mentions adherence to IEC standards (IEC 60825-1 and IEC 60601-2-22) for electrical and laser safety, which are general safety and performance standards for laser products, not specific clinical or technical performance acceptance criteria for hair reduction.
No Clinical Study Details: There is no mention of a human clinical study, sample sizes, data provenance, ground truth establishment methods, or expert involvement for evaluating the device's efficacy in hair removal or permanent hair reduction. The indications for use mention "stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime," which implies a need for clinical data to substantiate, but such data is not provided in this summary.

Therefore, many parts of your request cannot be fulfilled based on the provided input.

However, I can provide a general understanding of what such a table would look like and address the limited information available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the provided document does not include specific acceptance criteria or performance data for hair removal/reduction efficacy. If it did, a table might look something like this (hypothetical example):

Acceptance Criterion (Hypothetical)	Required Performance (Hypothetical)	Reported Device Performance (Not found in document)	Pass/Fail
Primary Endpoint: Hair Reduction Percentage	≥ 20% hair reduction at 6 months	No performance data reported	N/A
Secondary Endpoint: Subject Satisfaction	≥ 70% of subjects satisfied	No performance data reported	N/A
Safety Endpoint: Incidence of Adverse Events (e.g., burns)	< 5% incidence	No performance data reported	N/A
Safety/Electrical Performance: IEC 60825-1	Conformance	Reported conformance	Pass
Safety/Electrical Performance: IEC 60601-2-22	Conformance	Reported conformance	Pass

Information Not Found in the Document:

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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, as this is a laser device, not an AI diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a laser device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not applicable, as this is a laser device, not an AI/algorithm-based system requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Information Available in the Document:

The document ([3] K141063, H. Performance Data) states that the device demonstrated conformance with the following safety and general performance standards:

IEC 60825-1: General safety standard for laser products.
IEC 60601-2-22: Specific safety standard for surgical, cosmetic, therapeutic, and diagnostic laser equipment.

The submission is a 510(k) for substantial equivalence. The primary "proof" meeting acceptance criteria for this type of submission is the demonstration that the device's technical specifications and safety profile are comparable to a legally marketed predicate device, and that it conforms to relevant recognized safety standards. The document asserts that the LinScan System "was found to be substantially equivalent to the predicate device, the LEDA from Quantel Derma, in terms of technology, function and intended use" and that "there are no new questions of safety or efficacy raised" ([4] K141063, I. Conclusion).

Summary

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K141063

Section 5 JUL 15 2014

510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 03-08-2014 [21 CFR 807.92(a)(1)].

Applicant Name and Address [21 CFR 807.92(a)(1)] A.

GME German Medical Engineering GmbH.

Grimmstrasse 23

Bavaria, Germany 90491

Tel: +49 9131 934159 10

Fax: +49 9131 934159 99

B. Contact Information

Philosopher's River IIc

P O Box 106

Willow Creek, MT 59760

Tel: 406-209-3039

Fax: 406 2093039

Contact person: Mike Johnson M.D.

mike@philosophersriver.com

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K141063

Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] C.

Trade Name: LinScan System Device Common Name: Laser Instrument for Dermatology Classification Name: Laser Instrument, Surgical Powered 21 CFR 878.4810 Product Code: GEX Device Classification: Class II

D. Predicate Devices [21 CFR 807.92(a)(3)]

The LinScan System uses similar technology and physical output characteristics as the following predicate devices: K090762 LEDA from Quantel Derma GmbH

Device Description [21 CFR 807.92(a)(4)] E.

The LinScan is a diode laser system designed to be used in Dermatological practice for stable, long term hair reduction.

The LinScan System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button), which controls an applicator unit. The applicator unit contains the diode laser and scanner. The unit comes in two models: the LinScan 808 has an applicator with a 808 nm diode laser. The LinScan 980 has an applicator with a 980 nm diode laser.

The LinScan System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit.

A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the LinScan System.

Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.

5-2

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F. Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)]

The LinScan is compared to the predicate, the Quantel Derma LEDA. The indications for use and intended use for the LinScan are identical to the Quantel Derma LEDA. Below is a comparison table.

Characteristic	GME Linscan withapplicators LinScan 808 andLinScan 980	Quantel Derma LEDA Systemwith applicators LEDA EPI808 and LEDA EPI 980
Applicable 510(k)s	NA	K090762
Mode of Operation	Pulsed diode laser	Pulsed diode laser
Light Source	Laser diode	Laser diode
Light Delivery	Laser and scannerare in theApplicatorhandpiece	Laser and scanner are in the Applicatorhandpiece
Cooling of Skin	Sapphire providescontact cooling.	Sapphire provides contact cooling oroptional air cooling.
Treatment AreaSize	15 x 10 mm or 15x 50 mm	12 x 12 mm or 12 x 50 mm
Peak Power	Up to 300W	Up to 350 W
Fluence(Energy Densityper Flash)	4-100 J/cm²	15-60 J/cm² (LEDA EPI 808)15-90 J/cm² (LEDA EPI 980)
Pulse Widths	4-100 ms	6-60 ms
Repetition Rate	0.5 to 2 pulses persecond dependingon energy	0.5 to 1 pulse per second depending onenergy.
System Cooling	Self contained,closed watercirculation system	Self contained, closed water circulationsystem
Wavelength	808 nm (LinScan808)980 nm (LinScan980)	808 nm (LEDA EPI 808)980 nm (LEDA EPI 980)
Beam Mode	Multimode	Multimode
Beam DivergenceAngel	1º Fast Axis23.8° Slow Axis	Not known
Aiming Beam	Red aiming beamlaser class II	No aiming beam
Controls	Footswitch orhandswitch	Footswitch
ElectricalRequirements	110-240 V~~50Hz,110-230 V~~60Hz,16 A (max. 1.75kW)	115 - 230 V ± 10% ~ 50 Hz / 60 Hz10 A (max. 1.1 kW)
Power CalibrationMethod	Diode currentcalibrated byexternal powerruler	Diode current calibrated by externalpower ruler
SterilizationAspects	Applicator isdisinfectedbetween patients.	Applicator is disinfected betweenpatients.
Pulse Formation	CW currentswitched on / off	CW current switched on / off
Pulse TrainDuration	4 ms - 100 ms	6 ms - 60 ms
Beam Diameter	1 mm x 15 mm	1 mm x 12 mm
Duty Cycle	< 100%	< 100%
Pulse Controls	Fluence, pulseduration	Fluence, pulse duration
Display	Touch ScreenControl Panel	Touch Screen Control Panel

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Indications for Use [21 CFR 807.92(a)(5)] G.

The GME LinScan System with the applicators LinScan 808 and LinScan 980 is indicated for hair removal and permanent hair reduction defined as the stable, longterm reduction in hair counts at 6, 9,or 12 months following a treatment regime.

H. Performance Data [21 CFR 807.92(b)(2)]

The Guidance Document, Laser Products -- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice 50) June 24, 2002 was used. Third party testing reports for IEC 60825-1 and IEC 60601-2-22 were submitted.

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K141063

I. Conclusion [21 CFR 807.92(b)(3)]

The GME LinScan was found to be substantially equivalent to the predicate device, the LEDA from Quantel Derma, in terms of technology, function and intended use. The indications for use are identical to the previously cleared device (K090762) Quantel Derma LEDA: We believe that there are no new questions of safety or efficacy raised by the introduction of the LinScan Diode Laser System.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its body, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2014

GME German Medical Engineering GmbH % Mike Johnson, M.D. Philosopher's River LLC P.O. Box 106 Willow Creek, Montana 59760

Re: K141063

Trade/Device Name: GME LinScan System 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: June 18, 2014 Received: June 26, 2014

Dear Dr. Johnson:

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

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Page 2 - Mike Johnson, M.D.

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 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.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (it known) K141063

Device Name

GME LinScan System

Indications for Use (Describe)

The GME LinScan System with the applicators LinScan 980 is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9,0r 12 months following a treatment regime.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -S 2014.07.14 12:09:29 -04'00' For BSA

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden lime for this collection of information is estimated to average 79 hours per response, including the time to review Instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.