The GentleMAX Family of Laser Systems is indicated for temporary hair reduction. Stable longterm 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. 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

The GentleMAX Family of Laser Systems is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 keratoses, nevi, chloasma, verrucae, skin tags, keratoses, 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.

The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Treatment of wrinkles.

Device Description

The Candela GentleMAX Family of Lasers 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.

Each laser head contains the appropriate solid state laser rod and high intensity xenon flashlamps to excite the laser medium. The laser heads are water cooled with a self contained circulating water system that includes a water to air heat exchanger so the system can be fully air-cooled. The temperature of the laser heads are regulated by the circulation of distilled water at a controlled temperature.

A high voltage power supply is used to charge a storage capacitor which provides energy to the flashlamps. An IGBT (high voltage switch) is used to discharge the capacitor through the flashlamp. Each laser head has its own dedicated IGBT switch which is how the system controls which wavelength is produced. The resulting flash of the flashlamp excites the laser rod which causes emission of a pulse of laser energy.

The Candela GentleMAX Laser System delivers laser energy with various pulse durations from 0.25 milliseconds to 300 milliseconds. The output of this laser is delivered to the area of reamment by means of a lens coupled user replaceable optical fiber with a treatment her and are artacted to its distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration).

Energy from the laser is directed to the target area via optical fiber handpiece delivery system. The Dynamic Cooling Device provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 1.5, 3, 6, 8, 10, 12, 15 and 18 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.

A microprocessor based system controller is used to monitor and direct all system functions. Operators of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via a touch screen and display panel. The touch screen panel can also be used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The GentleMAX Family of Laser Systems are designed with six major components:

1. High voltage power supply and modulator system
1. Optical laser head
1. Circulator system
1. Optical delivery system
S. Software control system
1. Dynamic cooling device

The Candela GentleMAX Family of Laser Systems are equipped with safety interlock systems to protect patients and operators.

AI/ML Overview

The Candela GentleMAX Family of Laser Systems is a medical device for dermatological treatments. The 510(k) summary indicates that the device has comparable performance to its predicate devices, but it does not contain a study or data that assesses its performance against specific acceptance criteria.

The provided document is a 510(k) premarket notification. For devices cleared through the 510(k) pathway, the primary mechanism for demonstrating safety and efficacy is to show substantial equivalence to a legally marketed predicate device. This typically involves demonstrating that the new device has similar intended uses, technological characteristics, and performs as safely and effectively as the predicate without raising new questions of safety or effectiveness. Often, comparison to predicate device specifications and existing performance data for predicate devices is used rather than new, extensive clinical studies with specified acceptance criteria as might be seen for a PMA (Premarket Approval) submission.

Therefore, many of the requested details about acceptance criteria, study methodologies, and ground truth establishment are not typically found in a 510(k) summary that relies on substantial equivalence.

Here's a breakdown of the information as it relates to your request, indicating where information is present or absent based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated as such in 510(k))	Reported Device Performance (from 510(k) showing equivalence)
Intended Uses:	The Candela GentleMAX Family of Laser Systems has the same intended uses as the predicate devices.
- Temporary hair reduction (755nm)	Indicated for temporary hair reduction, stable long-term or permanent reduction of hair, on all skin types (Fitzpatrick I-VI) including tanned skin.
- Treatment of benign pigmented lesions (755nm)	Indicated for treatment of benign pigmented lesions.
- Treatment of wrinkles (755nm)	Indicated for treatment of wrinkles.
- Photocoagulation of dermatological vascular lesions (755nm)	Indicated for the photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
- Removal of unwanted hair (1064nm)	Indicated for the removal of unwanted hair, stable long-term or permanent hair reduction, and treatment of PFB on all skin types (Fitzpatrick I-VI) including tanned skin.
- Photocoagulation and hemostasis of pigmented and vascular lesions (1064nm)	Indicated for photocoagulation and hemostasis of pigmented and vascular lesions (e.g., port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins).
- Coagulation and hemostasis of soft tissue (1064nm)	Indicated for coagulation and hemostasis of soft tissue.
- Treatment of benign pigmented lesions (1064nm)	Indicated for benign pigmented lesions (e.g., lentigos, solar lentigos, cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos).
- Reduction of red pigmentation in hypertrophic and keloid scars (1064nm)	Indicated for the reduction of red pigmentation in hypertrophic and keloid scars.
- Treatment of wrinkles (1064nm)	Indicated for treatment of wrinkles.
Operating Principles:	Utilizes similar operating principles to the predicate devices.
Key Design Aspects:	Matches key design aspects including similar spot size, the same wavelengths, and the same maximum delivered fluence as the predicate devices.
Safety and Performance Standards:	Conforms to the Laser Performance Standard (21 CFR 1040), IEC (EN) 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60825-1, and IEC 60601-2-22.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not describe a specific clinical "test set" with a sample size or data provenance because it relies on substantial equivalence to predicate devices, rather than new, independent clinical performance data. The "testing" section primarily refers to compliance with laser and electrical safety standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable or provided. The submission does not detail a study that required expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable or provided. There is no described test set requiring an adjudication method.

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

This information is not applicable or provided. The device is a laser system for dermatological treatments and not an AI-assisted diagnostic device, so an MRMC study with human readers/AI assistance is not relevant to this 510(k) submission.

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

This information is not applicable or provided. The device is a physical laser system, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable or provided as there is no specific performance study against a ground truth described in the document. Substantial equivalence relies on comparing the device's characteristics and intended use to those of already approved predicate devices.

8. The Sample Size for the Training Set

This information is not applicable or provided. The device is a physical laser system, and the submission does not mention any machine learning or AI components that would require a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable or provided for the reasons stated in point 8.

Summary

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E. GentleMAX Family of Laser Systems 510k Summary

General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela GentleMAX Family of Laser Systems using 755 nm Alexandrite laser, which is substantially equivalent to previously marketed devices intended for the photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Submitted by:	Candela Corporation530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	Sam Wade, VP of Quality and Regulatory Affairs
Date prepared:	August 1, 2011
Classification:	Class II GEX Product Code(21 CFR § 878.4810 Laser Surgical Instrument for use inGeneral and Plastic Surgery and in Dermatology)
Common Name:	Dermatology Laser, GentleMAX Family of Laser Systems
Predicate Devices:	GentleLASE Family of Laser Systems(K111144)Candela 3630 Laser System(now named Candela GentleMAX Laser System)(K063074)

Description:

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distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration).

The GentleMAX Family of Laser Systems are designed with six major components:

1. High voltage power supply and modulator system
1. Optical laser head
1. Circulator system
1. Optical delivery system
S. Software control system
1. Dynamic cooling device

The Candela GentleMAX Family of Laser Systems are equipped with safety interlock systems to protect patients and operators.

Testing:

As laser products, the GentleMAX Family of Laser Systems conform to the Laser Performance Standard (21 CFR 1040). In addition, the GentleMAX Family of Laser Systems conform to IEC (EN) 60601-1 Medical Electrical Equipment- Gen'1 Requirements for Safety, IEC 60601-1-2 Medical Electrcal Equipment- Electromagnetic Compatibility, IEC 60601-1-4 Medical Electrical Equipment- Programmable Electrical Medical Systems, IEC 60825-1, and IEC 60601-2-22 Medical Electrical Equipment- Safety of Diagnostic and Therapeutic Laser Equip.

Summary of Substantial Equivalence:

The Candela GentleMAX Family of Laser Systems have intended uses, utilizes similar operating principles and matches key design aspects, including similar spot size, the same wavelengths and the same maximum delivered fluence as the predicate devices. On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela Corporation believes that the Candela GentleMAX Family of Laser Systems are substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20995-0002

Candela Corporation % Mr. Sam Wade VP of Quality and Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778-1886

0CT - 5 2011

Re: K112715

Trade/Device Name: GentleMAX Family of Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class H Product Code: GEX Dated: September 16, 2011 Received: September 20, 2011

Dear Mr. Wade:

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) imo either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your devine (ran be found in the Code of Federal Regulations, Title 21, Paris 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Sam Wade

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 freporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH s) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Alili H Millham

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K (122) 5

Device Name: GentleMAX Family of Laser Systems

Indications for Use:

755mm

Nil R.P. Ogden for nti
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number K112715

Treatment of benign pigmented lesions.

Treatment of wrinkles.

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

1064nm

The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Treatment of wrinkles.

Prescription Use __ X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.