The GME LinScan Lite 808 Laser System 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 Lite 808 Laser System is a diode laser designed to be used in Dermatological practice 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.

The LinScan Lite 808 System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner.

The LinScan Lite 808 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 Lite 808 System.

Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore. Specifically, 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 text describes a 510(k) summary for the GME LinScan Lite 808 Laser System, which is a medical device for hair removal and permanent hair reduction. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It is crucial to understand that this document does NOT describe the performance of an Artificial Intelligence (AI) device, nor does it present "acceptance criteria" or a "study that proves the device meets acceptance criteria" in the context of AI device performance.

The acceptance criteria and study described in this document are related to the substantial equivalence of a laser system to a predicate device, focusing on its physical characteristics, safety standards (IEC certifications), and intended use, rather than an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fulfill your request for information related to an AI device's acceptance criteria and performance study derived from this document. The document discusses:

Device Type: A laser system for hair removal.
Regulatory Pathway: 510(k) premarket notification for substantial equivalence.
Performance Data (as presented): Conformance to IEC standards (e.g., IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-2), which are safety and electrical performance standards for medical electrical equipment and laser products. These are not performance metrics for an AI algorithm.
No mention of:
- AI algorithms or their performance.
- Test sets, training sets, or ground truth for AI.
- Expert readers or adjudication for AI.
- MRMC studies for AI.
- Sensitivity, specificity, AUC, or other typical AI performance metrics.

In summary, the provided text does not contain any information about an AI device's acceptance criteria or performance study.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 23, 2018

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

Re: K180518

Trade/Device Name: GME LinScan Lite 808 Laser 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 11, 2018 Received: June 21, 2018

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

David Krause -S

for 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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K180518

Section 4

Indications for Use

510(k) Number (if known): NA______________________________________________________________________________________________________________________________________________

Device Name: GME LinScan Lite 808 Laser System

Indications for Use:

4-1

X Prescription Use (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)

Prescription Use______________________________________________________________________________________________________________________________________________________________

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Section 5

510(k) Summarv

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 07-18-2018 [21 CFR 807.92(a)(1)].

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

GME German Medical Engineering GmbH.

Grimmstrasse 23

Bavaria, Germany 90491

Tel: +49 9131 934159 0

Fax: +49 9131 934159 99

B. Contact Information

Philosopher's River llc

P O Box 106

Willow Creek, MT 59760

Tel: 406-209-3039

Fax: 406 2093039

Contact person: Mike Johnson M.D.

mike(@)philosophersriver.com

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

Trade Name: LinScan Lite 808 Laser 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)]

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The LinScan Lite 808 Laser System uses similar technology and physical output characteristics as the following predicate device: K141063 GME LinScan 808/980 Svstem

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

The LinScan Lite 808 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 Lite 808 System.

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

The GME LinScan Lite 808 System is compared to the predicates • GME LinScan 808/980 System K141063

The indications for use and classification for the LinScan Lite 808 System are equivalent to the predicate. Below is a comparison table.

Characteristic	GME LinScan Lite 808 LaserSystem	GME LinScan 808 and LinScan 980
	"LinScan Lite"	"LinScan 808/980"
Applicable 510(k)s	NA	K141063
Panel/	General and Plastic Surgery	General and Plastic Surgery
Product Code/Regulation Number	GEX21 CFR 878.4810	GEX21 CFR 878.4810

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Indications for Use Statement	The GME LinScan Lite808System is indicated for hairremoval and permanent hairreduction defined as the stable,long-term reduction in hair countsat 6, 9,or 12 months following atreatment regime.	The GME LinScan System with theapplicators LinScan 808 and LinScan980 is indicated for hair removal andpermanent hair reduction defined as thestable, long-term reduction in haircounts at 6, 9,or 12 months following atreatment regime.
Classification	Class IV	Class IV
Common Name	Pulsed diode laser	Pulsed diode laser
Mechanism of Action	Heats chromophores (pigments)and water in the skin through theabsorption of light. The heatingdenatures proteins of the hairfollicle.	Heats chromophores (pigments) andwater in the skin through the absorptionof light. The heating denatures proteinsof the hair follicle.

The specifications for the LinScan Lite 808 System are equivalent to the predicates.
Below is a comparison table.

Characteristic	GME LinScanLite 808 Laser System"LinScan Lite"	GME LinScan 808 and LinScan980"LinScan 808/980"
Applicable 510(k)s	NA	K141063
Mode of Operation	Pulsed diode laser	Pulsed diode laser
Light Source	Laser diode	Laser diode
Light Delivery	Laser and scanner are in theApplicator handpiece	Laser and scanner are in the Applicatorhandpiece
Cooling of Skin	Sapphire provides contact cooling.	Sapphire provides contact cooling.
Treatment Area Size	13 x 10 mm25 x 10 mm,	15 x 10 mm,15 x 50 mm
Peak Power	Up to 150 W	Up to 300W
Power Density	2000 W/cm2	2000 W/cm2
Fluence(Energy Density per Flash)	4-100 J/cm²	4-100 J/cm²
Pulse Widths	4-100 ms	4-100 ms
Repetition Rate	up to 2Hz	up to 2Hz
System Cooling	Self contained, closed watercirculation system	Self contained, closed water circulationsystem
Wavelength	808 nm Applicator.	808 nm or980 nm Applicator
Beam Mode	Multimode	Multimode
Aiming Beam	None	Red aiming beam laser class II
Controls	Footswitch or handswitch	Footswitch or handswitch
Electrical Requirements	100V-240V @ 50/60Hz, max. 900W	110V-240V at 50Hz, 110V-220V at60Hz, max. 1750W
Power Calibration Method	Diode current calibrated by externalpower ruler	Diode current calibrated by externalpower ruler
Sterilization Aspects	Applicator is cleaned betweenpatients.	Applicator is cleaned between patients.
Pulse Formation	CW current switched on / off	CW current switched on / off
Pulse Duration	4 ms - 100 ms	4 ms - 100 ms
Beam Diameter	0.75 mm x 10 mm	1 mm x 15 mm
Duty Cycle	< 100%	< 100%
Pulse Controls	Fluence, pulse duration	Fluence, pulse duration
Display	Touch Screen Control Panel	Touch Screen Control Panel

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

The GME LinScan Lite 808 System 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.

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 56) January 19, 2018 was used. Testing reports for IEC 60825-1 and IEC 60601-2-22 were submitted. Testing reports for IEC 60601-1 and IEC 60601-2 were also submitted.

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

The GME LinScan Lite 808 Laser System is substantially equivalent to the predicate device, the GME LinScan 808/980 System; in terms of technology, function and indications for use. There are no new questions of safety or efficacy raised by the introduction of the LinScan Lite 808 Diode Laser System.

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.