The Flaxelase 600 Series Ion Laser is intended for use in the treatment of selected yascular and pigmented lesions of the skin. Laser light of a selected wavelength is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue.

Flex-Lase 600 Ion Laser is intended for use in the the a treatment of salected pigmented and vascularized lesions of the skin. Representative indications for use are:

Flex-Lase Model 640 Laser System For vascular lesions: (Yellow - 568 nm)

Capillary Hemangioma (port wine hemangioma)
Strawberry hemangioma
Telangectasia
Rosacea

For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm).

Freckles
Age Spots
Cafe-au-lait
Lentigo

Flex-Lase Model 620 Laser System For Wascular Sesions: (Blue/Green - 488 nm and 514.5 nm)

Capillary Hemangioma (port wine hemangioma)
Strawberry Hemangioma
Telangectasia
Rosagea .

For pigmented lesions: (Green - p14.5 mm)

Freckles
Age Spots
Cafe-Au-Lait
Lentigo

Device Description

The Flex-Lase 600 Series Ion Laser submission covers all of the internal parts, subassemblies and components as well as the completed device. The Flex-Lase Model 640 is a coninuous wave krypton laser system emitting light at the 568 nm (yellow) and 520/530 nm (green) wavelengths. The Flex-Lase Model 620 is a continuous wave argon laser system emitting light at the 488 nm (blue) and the 514 nm (green) wavelengths.

Treatment beam output for the Flex-Lase Model 640 (krypton) is 1.0 Watt (yellow) and 3.0 Watts (yellow-green simultaneous). The power output for the Flex-Lase Model 620 (argon) is 5.5 watts blue-green or 2.0 watts green. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Flex-Lase 600 Series Ion Laser (in seconds) are 0.02, 0.05, 0.1. 0.25, 0.5, 1.0, and continuous.

Laser activation occurs by footswitch. Overall weight of the system is 112 lbs. (51 kg). The Flex-Lase 600 Series Ion Laser has a footprint of 16 X 24 inches (38 X 60 cm) and is 36 inches (90 cm) high.

The electrical power requirement is 208 VAC 40 amb single phase. Cooling is provided by external filtered flow-through tap water at a minimum rate of 2.5 gallons (9,5 liters) per minute.

Accessories available for use with the Flex-lase 600 Ton Laser include a fooysing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Flex-laser 600 series is not a computer controlled device.

AI/ML Overview

The provided text describes a medical device, the Flex-Lase 600 Series Ion Laser, and asserts its substantial equivalence to other commercially available lasers for treating vascular and pigmented lesions. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This is a regulatory pathway where a new device is shown to be as safe and effective as a legally marketed predicate device, rather than undergoing a de novo clinical trial with specific performance endpoints.

Therefore, many of the requested elements for describing acceptance criteria and a study demonstrating device performance cannot be extracted from the provided text.

Here's a breakdown of what can be inferred from the document regarding its regulatory submission and what cannot be answered:

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

Cannot be extracted. The document does not describe specific acceptance criteria (e.g., a target accuracy rate, sensitivity, specificity, or precision) for the Flex-Lase 600 Series Ion Laser itself, nor does it report performance metrics against such criteria. The "performance" described is in comparison to predicate devices, focusing on technical specifications rather than clinical outcomes with quantified performance.

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

Cannot be extracted. Since there is no described study with acceptance criteria, there is no mention of a test set, sample size, or data provenance from a performance study. The "data" provided is a comparison of technical features between the Flex-Lase and predicate devices.

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):

Cannot be extracted. Ground truth establishment is irrelevant in this context, as there is no performance study against a ground truth.

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

Cannot be extracted. Adjudication methods are relevant for clinical performance studies, which are not detailed in this document.

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:

Cannot be extracted. The device is a laser system, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study and AI performance improvement are not applicable to the information provided.

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

Cannot be extracted. This question is also not applicable as the device is a medical laser, not an algorithm. The document describes the specifications and intended use of a physical laser device.

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

Cannot be extracted. As there is no described performance study, there's no mention of ground truth. The "proof" of safety and effectiveness relies on comparison to predicate devices.

8. The sample size for the training set:

Cannot be extracted. There is no training set mentioned because this is not an AI/machine learning device requiring training data.

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

Cannot be extracted. Not applicable, as there is no training set for this type of device.

What the document does describe (relevant to regulatory submission):

The document effectively fulfills the requirements for a 510(k) Pre-market Notification by demonstrating substantial equivalence to predicate devices. Key aspects of this demonstration include:

Comparison of Device Characteristics: Extensive tables (pages 4-7) compare various technical specifications of the Flex-Lase models (620 and 640) with several predicate devices (HGM K1, Metalaser Vasculase, Coherent Artisan). These characteristics include:
- Type of laser (Continuous wave argon/krypton, Copper Vapor)
- Wavelength
- Exposure Time
- Output Mode
- Beam Delivery
- Stability of Output Energy
- Spot Size
- Energy density
- Aiming beam
- Cooling
- Electrical Requirements
- Indications for Vascular Lesions
- Indications for Pigmented Lesions
Statement of Substantial Equivalence: The document explicitly states that the Flex-Lase 600 Series Ion Laser "is substantially equivalent" to the named predicate devices for both vascular and pigmented lesions based on "materials, intended use, method of manufacture, design, precautions, cautions, and treatment parameters" being "substantially the same."
Predicate Device K Numbers: K-numbers for some predicate devices (HGM K1: K913428, K913569; Metalaser Vasculase: K903883) are provided, which is typical for substantial equivalence claims.

In conclusion, the document provides information for a regulatory clearance based on substantial equivalence, not a performance study against specific acceptance criteria.

Summary

{0}------------------------------------------------

NOV 26 1996

K9633/9

Flex-Lase 600 Series Ion Laser American Laser Medical November 7, 1996

Summary of Safety and Effectiveness Information

Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

Company Name/Contact;

Company: American Laser Medical
1832 South 3850 West
Salt Lake City, UT 84104
(801) 972-1311, FAX (801) 972-5251

Contact: Mr. Daniel Hoefer Regulatory Affairs American Laser Medical 1832 South 3850 West Salt Lake City, UT 84104 (801) 972-1311, FAX (801) 972-5251
Name of Device:

Flex-Lase 600 Series Ion Laser Trade Name:

Common Name: Dermatology Laser

Classification:

Powered surgical laser instruments are assigned the unique device classification code 79GEX. The published physical description of this device is found in 21 CFR, & 878.4810 (a) specifically device classification section (2) . This describes argon laser systems. The American Laser Medical device may be configured as either an argon laser system or as system, however American Medical Laser krypton laser a maintains that there is no substantial difference between argon and krypton lasers for the purpose of classification. medical these lasers are considered Class II Presently, devices.

{1}------------------------------------------------

Flex-Lase 600 Series Ion Laser American Laser Medical November 7, 1996

Description of Device:

The Flex-Lase 600 Series Ion Laser submission covers all of the internal parts, subassemblies and components as well as The Flex-Lase Model 640 is a coninuous the completed device. wave krypton laser system emitting light at the 568 nm The Flex-Lase (yellow) and 520/530 nm (green) wavelengths. Model 620 is a continuous wave argon laser system emitting light at the 488 nm (blue) and the 514 nm (green) wavelengths.

Treatment beam output for the Flex-Lase Model 640 (krypton) is 1.0 Watt (yellow) and 3.0 Watts (yellow-green simultaneous). The power output for the Flex-Lase Model 620 (argon) is 5.5 The aiming beam is watts blue-green or 2.0 watts green. provided by an adjustable intensity incoherent white light Exposure times for the Flex-Lase 600 Series Ion Laser source. 0.02, 0.05, 0.1. 0.25, 0.5, 1.0, and (in seconds) are continuous.

The electrical power requirement is 208 VAC 40 amb single phase. Cooling is provided by external filtered flow-through tap water at a minimum rate of 2.5 gallons (9,5 liters) per minute.

Intended Use:

The Flaxelase 600 Series Ion Laser is intended for use in the treatment of selected yascular and pigmented lesions of the Laser light of a selected wavelength is used to skin, photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue.

Indications for Use:

Flex-Lase 600 Ion Laser is intended for use in the the a treatment of salected pigmented and vascularized lesions of the skin. Representative indications for use are:

{2}------------------------------------------------

Flex-Lase 600 Series Ion Laser American Laser Medica I
November 7, 1996

Flex-Lase Model 640 Laser System For vascular lesions: (Yellow - 568 nm)

Capillary Hemangioma (port wine hemangioma) 1.
Strawberry hemangioma 2.
1. Telangectasia
4 . Rosacea

For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm).

1. Freckles
Age Spots 2.
Cafe-au-lait 3.
4 . Lentigo

Flex-Lase Model 620 Laser System For Wascular Sesions: (Blue/Green - 488 nm and 514.5 nm)

Capillary Hemangioma (port wine hemangioma)
1. Strawberry Hemangioma
Telangectasia 6
Rosagea .

For pigmented lesions: (Green - p14.5 mm)

Freckles
1. Age Spots
Cafe-Au-Lait
Lentigo

Comparison of Device Characteristics:

For vascular lesions:

The Flex-Lase 600 Ion Leser System is substantially equivalent to the NGM Spectrum KI, the Metalaser Vasculase and the Coherent artisan already in gommercial distribution. una materials, Intended use, method of manufacture, design, procautions cautions . and treatment parameters warninga. are substantially the same.

For pigmented lesions:

The Flex-Lase 600 Series Ion Leser Bystem is supersurielly equivalent to the HGM Spectrum KI, the Matalaser Vasculass and the Coherent Artisan already in commercial distribution. ਿਸ਼ਰੂ ਫ

{3}------------------------------------------------

Flex-Lase 600 Series Ion Laser American Laser Medical, Inc.
November 7, 1996

materials, design, intended use, method of manufacture, warnings, cautions and precautions are substantially the same.

Feature comparison tables which follow illustrate the equivalence of features of the Flex-Lase 600 and equivalent available systems. See also appendix II for marketing materials on substantially equivalent devices.

{4}------------------------------------------------

ين جاء

. • •

Laser Equivalency Table Vascular Lesions

	FLEX-LASEMODEL 620	FLEX-LASEMODEL 640	HGH K1	METALASERVASCULASE	COHERENTARTISAN
Type	Con-tinuous.waveargon	Continuouswavekrypton	ContinuousWavekrypton	CopperVaporLaser	ContinuouswaveArgon/Dye
Wavelength(nano-meters)	514, or488/514	568, or568/520-530	568,520/530	511, 578	514 only,or488/514,or 577-630selectable
ExposureTime (sec.)	0.02,0.05,0.1,0.25,0.5, 1.0,and cont.	Same	0.05, 0.1,0.2, 0.5,1.0, 2.0,5.0, andcontinuous	0.075,0.1, 0.2,0.3, andcontinuous	0.01,0.02,0.05, 0.1,0.2, 0.5,1.0, 2.0,5.0, cont.
Output Mode	Multimode	Multimode	Multimode	Multimode	Multimode
BeamDelivery	Handpiecevia fiberoptic	Handpiecevia fiberoptic	Handpiecevia fiberoptic	Handpiecevia fiberoptic	Handpiecevia fiberoptic
Stabilityof OutputEnergy	+/- 10%	+/- 10%	+/- 10%	+/- 20%	+/- 5%
Spot Size(mm)	0.25,0.5, 1.0	0.25, 0.5,1.0	0.1, 0.2,1.0	0.1, 0.2,1.0	0.1, 0.25,0.5, 1.0,fixed,variable0.2-2.5
Energydensity	2-30J/cm²	2-30 J/cm²	2-30 J/cm²	4-15 J/cm²	2-30 J/cm²
Aimingbeam	Adjust-able in-coherentwhitelightsource	Adjustableincoherentwhitelightsource	HeNe(633nm)adjustableto 5 mW	HeNe (633nm)	HeNe (633nm)
	FLEX-LASEMODEL 620	FLEX-LASEMODEL 640	HOM KI	METALASERVASCULASE	COHERENTARTISAN
Cooling	Filteredflow-throughtap water2.5gal/min	Filteredflow-throughtap water2.5gal/min	Internalliquidcooled	Air-cooled,40F-80Fambientair temp.	Filteredflow-throughtap water2.5gal/min
ElectricalRequire-ments	208-240VAC 40ampsinglephase50/60 Hz	208-240VAC 40 ampsinglephase50/60 Hz	208-240VAC 40 amp50/60 Hzsinglephase	208 VAC+/- 10%,20 amp60Hzsinglephase	208 VAC 50amp 50/60Hz 3 phase
IndicationsforVascularlesions	Capillary(portwine)heman-gioma,Straw-berryheman-gioma,Telangec-tasia,Rosacea	Capillaryor portwinehemangiomaStrawberryhemangiomaTelangec-tasiaRosacea	VascularLesions( same )	VascularLesions( same )	VascularLesions( same )
K Number			K913428,K913569	K903883	na
	FLEX-LASEMODEL 620	FLEX-LASEMODEL 640	HGM K1	METALASERVASCULASE	COHERENTARTISAN
Type	Continuouswaveargon	Continuouswavekrypton	ContinuousWavekrypton	CopperVaporLaser	ContinuouswaveArgon/Dye
Wavelength(nano-meters)	514, or488/514	568, or568/520-530	568,520/530	511, 578	514 only, or488/514, or 577-630selectable
ExposureTime (sec.)	0.02,0.05,0.1,0.25,0.5, 1.0,and cont.	Same	0.05, 0.1,0.2, 0.5,1.0, 2.0,5.0, andcontinuous	0.075,0.1, 0.2,0.3, andcontinuous	0.01,0.02,0.05, 0.1,0.2, 0.5,1.0, 2.0,5.0, cont.
Output Mode	Multimode	Multimode	Multimode	Multimode	Multimode
BeamDelivery	Handpiecevia fiberoptic	Handpiecevia fiberoptic	Handpiecevia fiberoptic	Handpiecevia fiberoptic	Handpiecevia fiberoptic
Stabilityof OutputEnergy	+/- 10%	+/-10%	+/-10%	+/-20%	+/- 5%
Spot Size(milli-meters)	0.25,0.5, 1.0	0.25, 0.5,1.0	0.1, 0.2,1.0 mm	0.1, 0.2,1.0 mm	0.1, 0.25,0.5, 1.0,fixed,variable0.2-2.5 mm
Energydensity	2-30 J/cm2	2-30 J/cm2	2-30 J/cm2	4-15 J/cm2	2-30 J/cm2
Aimingbeam	Adjust-able in-coherentwhitelightsource	Adjustableincoherentwhitelightsource	HeNe(633nm)adjustableto 5 mW	HeNe (633 nm)	HeNe (633 nm)
	FLEXI-LASEMODEL 620	FLEX-LASEMODEL 640	EGM K1	METALASERVASCULASE	COHERENTARTISAN
Cooling	Filteredflow-throughtap water2.5gal/min	Filteredflow-throughtap water2.5gal/min	Internalliquidcooled	Air-cooled,40F-80Fambientair temp.	Filteredflow-throughtap water2.5gal/min
ElectricalRequire-ments	208-240VAC 40ampsinglephase50/60 Hz	208-240VAC 40 ampsinglephase50/60 Hz	208-240VAC 40 amp50/60 Hzsinglephase	208 VAC+/- 10%,20 amp60Hzsinglephase	208 VAC 50amp 50/60Hz 3 phase
IndicationsforPigmentedlesions	Freckles,Agespots,cafe-au-lait,lentigo	Freckles,Age spots,cafe-au-laitlentigo	PigmentedLesions(same)	PigmentedLesions(same)	PigmentedLesions(same)
K Number			K913428,K913569	K903883	na

{5}------------------------------------------------

{6}------------------------------------------------

・・

...

. . ...

Laser Equivalency Table

Pigmented Lesions

{7}------------------------------------------------

: 翻 :

: ----:

.... ....

: : : : : : : : : : :

..............................................................................................................................................................................

"" "

റ്റ

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.