The Vbeam Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

595 nm:

General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia. rosacea, port wine stains, hemangioma, spider angioma, poikiloderma of civatte, and benign cutaneous lesions, such as warts, scars, striae, psoriasis and the treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris.

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

Device Description

The Vbeam Prima Laser system is designed as a transportable device that delivers laser energy at wavelengths of 595 nm (pulse-dye) or 1064 nm (Nd: YAG). The device is comprised of a main console, power supply, controlled electronics, firmware, software, cooling system, and handpieces. There is also an internal calibration port with an internal meter located in the system. The handpiece offers a set of distance gauges available in the following spot ranges: 3-7 mm, 7-11 mm, 11-15 mm, and 3 X 10 mm. The user selects treatment settings, such as fluence, number of pulses, and spot size selection via a color touch screen. The handpiece incorporates a Dynamic Cooling Device (DCD) into its handpiece that is designed to cool the skin surface during treatment, which consists of an electrically controlled spray nozzle, cryogen reservoir canister and an electronic control circuitry. The Vbeam Prima Laser System also offers an optional EverCool Delivery System Handpiece for skin cooling during treatment.

AI/ML Overview

The Vbeam Prima Laser System's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Electrical Safety and EMC	Compliance with recognized standards:	The device passed the required testing and is in full compliance with the following standards:
	- IEC 60825-1	- IEC 60825-1: Safety of Laser Products – Part 1: Equipment classification and requirements
	- IEC 60601-1-2	- 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	- IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
	- IEC 60601-2-22	- 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	Established based on predicate devices and ISO standards.	Biocompatibility was established based on predicate devices and the results of ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) series of testing.
Software Verification & Validation	Acceptable for software release according to FDA guidance.	Software verification and validation testing was conducted, and the 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."
Bench Testing (Cooling Performance)	DCD handpiece and Evercool handpiece produce similar cooling results.	A bench study was conducted to confirm that the DCD handpiece and Evercool handpiece can produce similar cooling results. (The document does not provide specific performance metrics, but states "confirm that the DCD handpiece and Evercool handpiece can produce similar cooling results," implying the criterion was met.)
Clinical Testing	Not needed due to similarity to predicate devices.	Based on the similarities of the device specifications, intended use, and indications for use between the Vbeam Prima Laser System and its predicate devices, no clinical studies were needed to support this 510(k) Premarket Notification. The safety and effectiveness are established by substantial equivalence to previously cleared devices.

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

Since no clinical studies were conducted for the Vbeam Prima Laser System due to its substantial equivalence to predicate devices, there isn't a "test set" in the traditional sense for clinical performance.

Electrical Safety and EMC: Testing was conducted on the device itself (Epic Pro 940, implicitly the Vbeam Prima or a prototype). This involved laboratory testing, not human subjects or patient data.
Biocompatibility: Testing was on materials of the device, according to ISO 10993 standards. This is laboratory testing.
Software Verification & Validation: Testing was on the software of the device. This is internal software testing.
Bench Testing (Cooling Performance): Testing was on the DCD and Evercool handpieces. This is laboratory testing.

Therefore, there is no human subject data provenance (country of origin, retrospective/prospective).

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

Not applicable, as no clinical studies were performed. The "ground truth" for the device's safety and effectiveness was established by its compliance with recognized standards and its technological similarity to legally marketed predicate devices, which had previously demonstrated safety and effectiveness through their own studies and clinical use.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies were performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done, as no clinical studies were performed. The Vbeam Prima Laser System is a physical medical device (laser system), not an AI algorithm that assists human readers.

6. Standalone (Algorithm Only) Performance

Not applicable, as the Vbeam Prima Laser System is a physical medical device, not an AI algorithm. Its performance is evaluated through engineering and biocompatibility testing, not AI algorithm standalone performance.

7. Type of Ground Truth Used

The "ground truth" for the Vbeam Prima Laser System's safety and effectiveness relies on:

Compliance with recognized international standards for electrical safety, electromagnetic compatibility, and biocompatibility.
Demonstrated equivalence of technological characteristics and intended use to predicate devices that have an established history of safe and effective use.

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set of data.

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

Not applicable, as this is a physical medical device, not an AI algorithm.

Summary

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June 5, 2018

Syneron-Candela Sharon Timberlake VP, Global Regulatory and Clinical Affairs 530 Boston Post Road Wayland, Massachusetts 01778

Re: K180593

Trade/Device Name: Vbeam Prima 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: March 2, 2018 Received: March 6, 2018

Dear Sharon Timberlake:

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, 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 (OS) regulation (21 CFR Part 820);

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Page 2 - Sharon Timberlake

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 mediation-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,

Jennifer R. Stevenson -S3

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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Indications for Use

510(k) Number (if known)

K180593

Device Name Vbeam Prima Laser System

Indications for Use (Describe)

1,064nm:

595 nm:

General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Vbeam® Prima Laser 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

March 1, 2018

2. APPLICANT NAME

Candela Corporation 530 Boston Post Road Wayland, MA 01778 P: (508) 358-0304 M: (617) 957-1434

3. OFFICIAL CORRESPONDENT

Sharon Timberlake, MSHS, RAC, CCRA VP, Global Clinical & Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, MA 01778 P: (508) 358-0304 M: (617) 957-1434 sharont@syneron-candela.com

4. DEVICE INFORMATION

Proprietary Name:	Vbeam® Prima Laser System
Common/Usual Name:	Pulse Dye and Nd: YAG Laser
Classification Name:	Laser surgical instrument for use in General and Plasticsurgery and in dermatology (21 CFR Section 878.4810)
Product Code:	GEX
Device Classification:	Class 2
Laser Classification:	Class IV

5. PREDICATE DEVICE

Candela Family of Pulsed Dye Laser Systems (K050673), primary predicate Cynosure Cynergy Multiplex Laser (K050779), additional predicate

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6. INTENDED USE

1,064 nm:

The Vbeam® Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

595 nm:

General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and Psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions.

Treatment of Inflammatory Acne Vulgaris.

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

7. DEVICE DESCRIPTION

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8. TECHNOLOGICAL CHARACTERISTICS

The Vbeam Prima Laser System has the same design, technological characteristics, operating principles, and intended use as the Candela Family of Pulsed Dye Laser Systems (K050673) and the Cynosure Cynergy Multiplex Laser (K050779). The devices all share the same technical features, such as calibration port, wavelengths, laser medium, delivery systems, power supply, cooling system, electronics, firmware, software and user display screen. The devices all share the same operating principles, such as energy, repetition rate, and offer a range of spot sizes. Any minor differences do not raise any new types of safety or effectiveness questions because the Vbeam Prima Laser System parameters are the same as the predicates.

9. PERFORMANCE DATA

The following performance data was included in the 510(k) Premarket Notification to support the substantial equivalence determination:

Electrical Safety and Electromagnetic Compatibility:

Electrical safety and electromagnetic compatibility testing of Epic Pro 940 was conducted according to the recognized standards. The device passed the required testing and is in full compliance with the 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 Vbeam Prima Laser System 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".

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Bench Testing

A bench study was conducted to confirm that the DCD handpiece and Evercool handpiece can produce similar cooling results.

Clinical Testing

Based on the similarities of the device specifications, intended use, indications for use between the Vbeam Prima Laser System and its predicate devices, no clinical studies were needed to support this 510(k) Premarket Notification.

10. STATEMENT OF SAFETY AND EFFECTIVENESS

The Vbeam Prima Laser System shares a similar design and intended use. Additionally, technological characteristics, including wavelengths, laser mediums, pulse width, spot sizes, energy, cooling systems, and repetition rate are similar between the Vbeam Prima Laser System and its predicate devices. The data presented in this 510(k) Premarket Notification further supports this conclusion since the results did not raise any new safety or efficacy concerns. Therefore, the Vbeam Prima Laser System is substantially equivalent to its predicate devices.

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.