The Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.

Intense Pulsed Light Energy / wavelengths (530 - 950nm) .
The 530 - 950nm intense pulsed wavelengths are indicated for:

The treatment of mild to moderate inflammatory Acne Vulgaris.

The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea. melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins. facial veins and venous malformations.

Intense Pulsed Light Energy / wavelengths (610 - 950nm) .

The 610 - 950nm intense pulsed wavelengths are indicated for:

The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

Device Description

The Energist ULTRA VPL™ System is a light based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm. The system is designed to be compact and self contained and includes the following features:

. Control console unit
Display panel .
Power supply ◆
Cooling system .
. Removable handpiece with integrated switch, lamp, filter and glass coupling block

AI/ML Overview

Here's an analysis based on the provided text:

Based on the provided 510(k) summary, the Energist ULTRA Variable Pulsed Light (VPL™) System did not undergo a study to prove it met specific quantitative acceptance criteria in the manner described in your request. Instead, the submission relies on demonstrating substantial equivalence to previously legally marketed predicate devices.

The document states: "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters." However, it does not detail the specific performance criteria or the results of such data.

Therefore, the requested tables and detailed study information for acceptance criteria cannot be fully extracted from the provided text, as this type of information is generally not required for a 510(k) submission when substantial equivalence is the primary pathway.

Here's what can be inferred or stated based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., specific clinical outcomes, percentages of reduction, safety thresholds). The implicit acceptance criteria are that the device performs equivalently to the predicate devices in terms of intended use and technological characteristics, and that any modifications do not raise new questions of safety or efficacy.
Reported Device Performance: The document only generally states: "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters." No specific quantitative performance results are provided in this summary.

Acceptance Criteria (Inferred from substantial equivalence approach)	Reported Device Performance (General Statement)
Equivalent intended use to predicate devices	Categorically stated as having "identical intended use" as the McCue predicate system.
Equivalent technological characteristics (or differences don't impact safety/efficacy)	Stated as having "identical technological characteristics except for modifications to the device software and high voltage component. These differences do not result in differences in performance or raise new questions of safety and efficacy." Also, "equivalent energy outputs" to the Cyden predicate.
Capable of providing outputs for required treatment parameters	"Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters."

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

No information is provided about a specific clinical "test set" with a defined sample size for the device's performance. The submission relies on equivalence to predicate devices, which would have had their own clinical data for market clearance.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable, as a de novo clinical study with expert ground truth establishment for this specific device's clinical performance is not described.

4. Adjudication Method:

Not applicable, as a de novo clinical study with expert adjudication is not described.

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

No mention of an MRMC study. This type of study is more common for diagnostic imaging AI systems comparing human readers with and without AI assistance, which is not the nature of this device.

6. Standalone Performance Study:

No mention of a standalone performance study in the context of clinical outcomes to establish effectiveness. The "performance data" mentioned is likely related to engineering and output parameters rather than clinical efficacy.

7. Type of Ground Truth Used:

Not applicable for this 510(k) summary, as it does not describe a new clinical study for this device where "ground truth" for clinical outcomes would be established for the purpose of a novel efficacy claim.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/Machine Learning device that utilizes a "training set" in the conventional sense.

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

Not applicable, as the device is not an AI/Machine Learning system with a "training set."

Summary of 510(k) Substantial Equivalence Approach:

The Energist ULTRA VPL™ System's clearance is based on demonstrating substantial equivalence to two predicate devices: McCue Energist ULTRA™ (K040659) and Cyden IFL Professional System (K050165).

Identical Intended Use: The new device claims an "identical intended use" to the McCue predicate device.
Identical Technological Characteristics (with minor differences): The new device claims "identical technological characteristics" to the McCue predicate, except for "modifications to the device software and high voltage component." The key assertion is that "These differences do not result in differences in performance or raise new questions of safety and efficacy."
Equivalent Principles, Mode of Action, and Energy Outputs: For the treatment of Acne Vulgaris, the device is stated to have "the same principles of operation, mode of action and equivalent energy outputs" as the Cyden predicate device.

Therefore, the "study" proving the device met "acceptance criteria" was implicitly the comparison to the predicate devices and the argument that its minor modifications did not negatively impact safety or efficacy, supported by general "performance data" (likely engineering/bench testing) showing it could achieve output parameters.

Summary

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Section 5 - 510(k) Summary

This 510(k) summary of safety and effectiveness for the Energist ULTRA variable pulsed light system has been prepared in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows relevant Office of Device Evaluation (ODE) guidance concerning the organisation and content of a 510(k) summary.

5.1 Applicant

Energist Ltd

5.2 Address

2 Clos Llyn Cwm , Enterprise Park, Swansea SA6 8QY, UK

5.3 Contact Person

Peter Smith, Engineering & Regulatory Affairs Manager Tel: +44 (0)1792 798768 Fax: +44 (0)1792 762099

5.4 Preparation Date

January 19, 2006

5.5 Device Trade Name

Energist ULTRA Variable Pulsed Light (VPL™) System

5.6 Device Common Name

Intense Pulsed Light System

5.7 Device Classification

Laser surgical instrument for use in General and Plastic Surgery and Dermatology Product code: GEX 21 CFR 878.4810

5.8 Legally marketed Predicate Devices

McCue Energist ULTRA™, K040659 Cyden IFL Professional System, K050165

5.9 Device Description

. Control console unit
Display panel .
Power supply ◆
Cooling system .
. Removable handpiece with integrated switch, lamp, filter and glass coupling block

5.10 Intended Use

. Intense Pulsed Light Energy / wavelengths (530 - 950nm)

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The 530 - 950nm intense pulsed wavelengths are indicated for:

The treatment of mild to moderate inflammatory Acne Vulgaris.

The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

Intense Pulsed Light Energy / wavelengths (610 950nm) .
The 610 - 950nm intense pulsed wavelengths are indicated for:

The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

5.11 Comparison of Technological Characteristics

The Energist ULTRA VPL System has an identical intended use to the McCue predicate system and identical technological characteristics except for modifications to the device software and high voltage component. These differences do not result in differences in performance or raise new questions of safety and efficacy. The Energist ULTRA VPL System also has the same principles of operation, mode of action and equivalent energy outputs that are used by the Cyden predicate device to achieve the treatment of Acne Vulgaris. Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters. The Energist ULTRA VPL ™ System is therefore concluded to be substantially equivalent to both of the above named predicate devices and minor differences to the systems do not raise additional concerns of safety and efficacy.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings, facing right. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2006

Energist, Ltd. c/o Mr. Peter Smith Engineering & Regulatory Affairs Manager 2 Clos Llyn Cwm Enterprise Park Swansea City and County of Swansea SA6 AQY United Kingdom

Re: K060216

Trade/Device Name: Energist ULTRA™ VPL Intense Pulse Light System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 19, 2006 Received: January 27, 2006

Dear Mr. Smith:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Mr. Peter Smith

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your dryice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

060216 510(k) Number (if known): A

Device Name: ___ Energist ULTRA™ VPL Intense Pulse Light System

Indications for Use:

Intense Pulsed Light Energy / wavelengths (530 950nm) .
The 530 - 950nm intense pulsed wavelengths are indicated for:

The treatment of mild to moderate inflammatory Acne Vulgaris.

The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

Intense Pulsed Light Energy / wavelengths (610 - 950nm) .

The 610 - 950nm intense pulsed wavelengths are indicated for:

The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

(Over)

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)

Image /page/4/Picture/19 description: This image shows a document with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". It also states "Division of General, Restorative, and Neurological Devices". The document includes the section number and page number, with "Section 4" and "Page 2" written at the bottom. The 510(k) number is K060216.

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.