755mm: Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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 regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas).

1064nm: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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 regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

Device Description

The GentleMax Pro Plus contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.

AI/ML Overview

This document is a 510(k) premarket notification for the Candela GentleMax Pro Plus laser system, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. As such, the information you're asking for, particularly regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/algorithm-driven medical device, is not directly applicable to this submission.

This document pertains to a laser surgical instrument, not an AI or algorithm-based diagnostic/therapeutic device. Therefore, the concepts of "test set," "ground truth," "expert consensus," "MRMC studies," and "standalone performance" as they relate to AI model validation are not present here.

However, I can extract the relevant information about how this device's performance and safety were evaluated to demonstrate substantial equivalence.

Here's an analysis based on the provided text, addressing your points where applicable and explaining why others are not relevant:

Device Type: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (Product Code GEX). This is NOT an AI/algorithm-driven device requiring traditional AI model performance evaluation.

Acceptance Criteria and Reported Device Performance (as relevant for a laser system):

The "acceptance criteria" for this device are primarily based on demonstrating substantial equivalence to a predicate device (Candela GentleMAX Family of Lasers System, K140122) in terms of design, technological characteristics, intended use, and indications for use. The performance data provided are therefore related to safety and functional equivalency.

Acceptance Criterion (for Substantial Equivalence to Predicate)	Reported Device Performance (GentleMax Pro Plus)
Technological Characteristics Similarity	Same as Predicate (K140122) for many key features:- Wavelengths (755 nm & 1064 nm)- Laser Medium (Flashlamp-excited, Solid state Alexandrite and Nd:YAG laser)- Aiming Beam (Green diode laser)- Maximum Fluence (400 J/cm2 (ALEX), 520 J/cm2 (YAG))- Accuracy of Output (± 20%)- Operating Modes (Pulse)- Energy Delivery (Footswitch & finger switch)- Beam Delivery (Lens-coupled optical fiber)- Skin Cooling (Cryogen DCD)- System Cooling (Ambient Air)- Software/GUI/Touch Screen (Yes)- Dimensions & Weight- Power SupplyMinor Differences (not raising new safety/effectiveness questions):- Maximum Energy (J): Modified: 68 J ALEX; 90 J Nd:YAG (Predicate: 53 J ALEX; 80 J Nd:YAG). This indicates increased power.- Spot Size (mm): Modified: 1.5, 3, 3x10, 5, 6, 8, 10, 12, 15, 18, 20, 22, 24, 26 (Predicate: 1.5, 3, 3x10, 5, 6, 8, 10, 12, 15, 18). New, larger spot sizes added.- Repetition Rate (Hz): Modified: 1-10 Hz (Predicate: 1-10 Hz). Text notes "faster repetition rate" but table shows same range. This likely refers to increased maximum repetition rate within the 1-10Hz range for specific parameters, not a change in the overall range.- Pulse Duration (ms): Modified: 0.25 - 100 ms (new 2ms) (Predicate: 0.25 - 100 ms). This indicates the addition of a specific 2ms pulse setting option.
Same Intended Use & Indications for Use	The Intended Use/Indications for Use Statement is unchanged from the predicate device (K140122).
Compliance with Electrical Safety and EMC Standards	Complies with IEC 60825-1, IEC 60601-1-2, IEC 60601-1, IEC 60601-2-22.
Biocompatibility	Established based on predicate devices and results of ISO 10993-5 and ISO 10993-10 series of testing (acceptable).
Software Verification & Validation	Testing conducted and results were found acceptable for software release, performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".

Since this is not an AI/algorithm-driven device, the following points are not applicable and are not discussed in the provided 510(k) summary:

2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI model. Performance evaluation for this laser is primarily functional and safety testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No image-based "ground truth" or expert review process as would be needed for an AI diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. There's no AI model involved that requires a "training set."
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Evaluation for Substantial Equivalence:

The manufacturer asserted that the GentleMax Pro Plus is substantially equivalent to its predicate (Candela GentleMAX Family of Lasers System, K140122) because:

It has the same intended use and indications for use.
It shares similar design and technological characteristics. While some specifications like maximum energy, pulse duration (new 2ms option), and spot sizes (new larger ones) have changed, the manufacturer states these "minor differences do not raise any new types of safety or effectiveness questions because the GentleMax Pro Plus parameters are similar to the predicates."
It meets all relevant electrical safety and electromagnetic compatibility standards (IEC 60825-1, IEC 60601-1-2, IEC 60601-1, IEC 60601-2-22).
Its biocompatibility was established using existing predicate data and ISO 10993 testing.
Its software underwent verification and validation testing in accordance with FDA guidance, with acceptable results.
No clinical studies were needed to support this 510(k) due to the strong similarities in device specifications, intended use, and indications for use with the predicate device.

In essence, the "study that proves the device meets the acceptance criteria" for this 510(k) submission is the demonstration, through comparison to a predicate and adherence to relevant safety standards, that the new device is as safe and effective as a device already on the market. This is a common pathway for medical device clearances that are not introducing fundamentally new technologies or indications.

Summary

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May 26, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Candela Corporation Yverre Bobay Director, Regulatory Affairs 251 Locke Dr Marlborough, Massachusetts 01752

Re: K201111

Trade/Device Name: GentleMax Pro Plus 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: April 24, 2020 Received: April 27, 2020

Dear Yverre Bobay:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K201111

Device Name GentleMAX Family of Laser Systems

Indications for Use (Describe)

755mm:

Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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 regime. On all skin types (Fitzpatrick I- VI) including tanned skin.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas).

1064nm:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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 regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.

The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary GentleMax Pro Plus System

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92

1. DATE PREPARED

April 24, 2020

2. APPLICANT NAME

Yverre Bobay Global Director, Regulatory Candela Corporation 251 Locke Drive Marlborough MA 01752 M: (617) 669-6181 yverreb@candelamedical.com

3. Official Correspondent

Greg Wallender VP, Global Quality & Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, MA 01778 M: (925) 206-5439 gregw@candelamedical.com

4. DEVICE INFORMATION

Proprietary Name:	GentleMax Family of Laser Systems
Common/Usual Name:	Dermatology Laser System
Classification Name:	Laser surgical instrument for use in General and Plasticsurgery and in dermatology (21 CFR Section 878.4810,Product Code GEX)
Product Code:	GEX
Device Classification:	Class II
Laser Classification:	Class IV

5. PREDICATE DEVICE

Candela GentleMAX Family of Lasers System (K140122).

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6. INTENDED USE/INDICATION FOR USE

There are no new Intended Uses for the GentleMax Pro Plus. The Indications for Use Statement is unchanged for the GentleMax Pro Plus is as follows:

755mm:

Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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 regime. On all skin types (Fitzpatrick I- VI) including tanned skin.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.

The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

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7. DEVICE DESCRIPTION

8. TECHNOLOGICAL CHARACTERISTICS

The new GentleMax Pro Plus system has the same design, technological characteristics, operating principles, and intended use as the Candela GentleMax Family of Laser System (K140122). The devices share the same technical features, such as calibration port, wavelengths, laser medium, delivery systems, power supply, cooling system, electronics, firmware and user display screen. The devices share the same operating principles, such as energy but the Gentle Max Pro Plus offers a faster repetition rate, and offers larger spot sizes. Any minor differences do not raise any new types of safety or effectiveness questions because the GentleMax Pro Plus parameters are similar to the predicates.

Specifications	Modified CandelaGentleMax Pro Plus	Current CandelaGentleMax Pro
Manufacturer	Candela Corp.	Candela Corp.
K Number	Not Assigned	K140122
Product Code	GEX	GEX
RegulationNumber	878.4810	878.4810
Device Class	II	II
Indicationsfor Use	The GentleMax Family of Laser Systems isindicated for the following at the specifiedwavelength:755 nmTemporary hair reduction. Stable long-termor permanent reduction through selectivetargeting of melanin in hair follicles.Permanent hair reduction is defined as long-	The GentleMax Family of Laser Systems isindicated for the following at the specifiedwavelength:755 nmTemporary hair reduction. Stable long-termor permanent reduction through selectivetargeting of melanin in hair follicles.Permanent hair reduction is defined as long-

	term stable reduction in the number of hairs regrowing after a treatment regime.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 regime. On all skin types (Fitzpatrick I- VI) including tanned skin.Treatment of benign pigmented lesions.Treatment of wrinkles.The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).	term stable reduction in the number of hairs regrowing after a treatment regime.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 regime. On all skin types (Fitzpatrick I- VI) including tanned skin.Treatment of benign pigmented lesions.Treatment of wrinkles.The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
	1064nmRemoval of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 regime. The lasers are indicated on all skin types Fitzpatrick 1-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.	1064nmRemoval of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 regime. The lasers are indicated on all skin types Fitzpatrick 1-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
	Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.Treatment of wrinkles.1064nmTemporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)	Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.Treatment of wrinkles.1064nmTemporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
Laser Type	Flashlamp-excited, Solid state Alexandrite and Nd:YAG laser	Flashlamp-excited, Solid state Alexandrite and Nd:YAG laser
Aiming Beam	Green diode laser(520-550 nm)	Green diode laser(520-550 nm)
Wavelengths(nm)	755 & 1064	755 & 1064
Maximum	68 Joules (J) ALEX; 90 J	53 joules (J) ALEX; 80 J
Energy (J)	Nd:YAG	Nd: YAG
Accuracy ofOutput	± 20%	± 20%
MaximumFluence(J/cm2)	400 J/cm2 (ALEX)520 J/cm2 (YAG)	400 J/cm2 (ALEX)520 J/cm2 (YAG)
Spot Size(mm)	1.5 mm, 3 mm, 3x10 mm, 5 mm,6 mm, 8 mm, 10 mm, 12 mm, 15mm, 18 mm, 20 mm, 22 mm, 24mm, 26 mm	1.5 mm, 3 mm, 3x10 mm, 5 mm,6 mm, 8 mm, 10 mm, 12 mm, 15mm, 18 mm
RepetitionRate (Hz)	1 – 10 Hz	1 - 10 Hz
PulseDuration (ms)	0.25 - 100 ms (new 2ms)	0.25 - 100 ms
OperatingModes	Pulse	Pulse
EnergyDelivery	Footswitch & finger switch	Footswitch & Handpiece switch
BeamDelivery	Lens-coupled optical fiber	Lens-coupled optical fiber
Voltage andPower (30Aconfiguration)	200 V to 240 V~, 50/60 Hz,single phase, 4,600 VA or 20 A at230 V~	200 V to 240 V~, 50/60 Hz,single phase, 4,600 VA or 20 A at230 V~
Voltage andPower (20Aconfiguration)	200 V to 240 V~, 50/60 Hz,single phase, 3,600 VA or 16 A at230 V~	200 V to 240 V~, 50/60 Hz,single phase, 3,600 VA or 16 A at230 V~
SystemCooling	Ambient Air	Ambient Air
Skin Cooling	YesCryogen (DCD)	YesCryogen (DCD)
Software/GUI/Touch Screen	Yes	Yes
Dimension inInches(H x W x L)	42 x 18 x 27	42 x 18 x 27
Weight(Pounds)	260	260
Power Supply	Yes	Yes

Comparison Table of Technological Characteristics

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K201111

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9. PERFORMANCE DATA

The following performance data supports the substantial equivalence determination:

Electrical Safety and Electromagnetic Compatibility Standards

IEC 60825-1: Safety of Laser Products – Part 1: Equipment classification and requirements
IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for safety - collateral standard: electromagnetic compatibility (EMC)requirements and test
. IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
. IEC 60601-2-22: Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Biocompatibility

The biocompatibility of the GentleMax Pro Plus has been established based on the predicate devices and the results of ISO 10993-5 and ISO 10993-10 series of testing.

Software Verification & Validation

Software verification and validation testing was conducted and results demonstrated that testing results were found acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".

Clinical Testing

Based on the similarities of the device specifications, intended use, indications for use between the GentleMax Pro Plus and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.

10. STATEMENT OF SAFETY AND EFFECTIVENESS

The GentleMax Pro Plus and shares a similar design and intended use to its predicate (K140122). Additionally, technological characteristics, including wavelengths, laser mediums, pulse width, spot sizes, energy, cooling systems, and repetition rate are similar between the GentleMax Pro Plus and its predicate devices. The modifications to the device do not raise new types of questions regarding safety and efficacy, and the data presented in this 510(k) Premarket Notification supports that the device 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.