GREENTON ECOLITE IPL SYSTEM by GREENTON (LONDON) LTD.

The Greenton Ecolite IPL System is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions and inflammatory acne (ache vulgaris).

Device Description

The Greenton Ecolite IPL System is a pulsed light, wavelength range adjustable system. It provides selectable handpiece aperture sizes for a variety of applications. Light emission activation is by foot switch. Overall weight of the system is 110 lbs., and the size is 13.8" X 19" X 40". Electrical requirement is 110 VAC, 15A, 50/60 Hz, single phase.

AI/ML Overview

This submission describes the Greenton Ecolite IPL System, an Intense Pulsed Light (IPL) system.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance:

The document states: "The Greenton Ecolite IPL System is identical to the Quanta System Eterna Giovinezza, has the same indications for use, the same principle of operation, and the same wavelength range and pulse energy range as the predicate device."

This implies that the acceptance criteria for the Greenton Ecolite IPL System are met by demonstrating its equivalence to the predicate device, the Quanta System Eterna Giovinezza (K051113). The performance of the Greenton Ecolite IPL System is considered acceptable if it operates identically and within the same specifications as the predicate device for the stated indications.

However, the document explicitly states:

Nonclinical Performance Data: None
Clinical Performance Data: None

Therefore, there is no direct demonstration of the Greenton Ecolite IPL System's performance against specific, quantifiable acceptance criteria. Its acceptance is based purely on substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, a conventional table of acceptance criteria and reported device performance cannot be generated because:

No explicit, measurable acceptance criteria for the Greenton Ecolite IPL System are given (e.g., "achieves X% reduction in hair growth," or "clears Y% of lesions").
No performance data for the Greerton Ecolite IPL System is reported.

Instead, the acceptance hinges on the following comparison:

Acceptance Criterion (Implied)	Reported Device Performance (Implied)
Identity to predicate device	Greenton Ecolite IPL System is identical to Quanta System Eterna Giovinezza (K051113).
Same indications for use	Greenton Ecolite IPL System has the same indications for use as the predicate.
Same principle of operation	Greenton Ecolite IPL System has the same principle of operation as the predicate.
Same wavelength range	Greenton Ecolite IPL System has the same wavelength range as the predicate.
Same pulse energy range	Greenton Ecolite IPL System has the same pulse energy range as the predicate.

Study Details:

Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study was performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment was performed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set was used.
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 a medical device, not an AI or diagnostics software, and no MRMC study was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (pulsed light system), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established for this device, as no clinical performance data was provided.
The sample size for the training set: Not applicable. No training set was used as no AI/machine learning component is mentioned, and no clinical data was presented.
How the ground truth for the training set was established: Not applicable.

Summary Conclusion based on the provided text:

The Greenton Ecolite IPL System received 510(k) clearance based solely on its substantial equivalence to a previously cleared predicate device (Quanta System Eterna Giovinezza, K051113). The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." Therefore, no studies were conducted to demonstrate the device's performance against specific acceptance criteria or to establish any ground truth. Its acceptance is predicated on the assumption that if it is identical in design and operation to a legally marketed equivalent device, it raises "no new safety or effectiveness questions."

Summary

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K062"72)

510(K) Summary

Submitter: Greenton (London) Ltd. 56 Ainsdale Road London W5 1JX UNITED KINGDOM
Contact: Robert T. Handren, Jr., M.S. Handren Associates, Inc. 5818 Princess Caroline Place Leesburg, FL 34748 352 250 8892 cell 352 314 8829 phone 352 314 3022 fax

Date Summary Prepared: July 17, 2006

Device Trade Name: Greenton Ecolite IPL System

Common Name: Pulsed Light system

Classification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810

Equivalent Device: Quanta System Eterna Giovinezza (K051113)
Device Description: The Greenton Ecolite IPL System is a pulsed light, wavelength range adjustable system. It provides selectable handpiece aperture sizes for a variety of applications. Light emission activation is by foot switch. Overall weight of the system is 110 lbs., and the size is 13.8" X 19" X 40". Electrical requirement is 110 VAC, 15A, 50/60 Hz, single phase.

Intended Use: The Greenton Ecolite IPL System is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions and inflammatory acne (ache vulgaris).

Comparison: The Greenton Ecolite IPL System is identical to the Quanta System Eterna Giovinezza, has the same indications for use, the same principle of operation, and the same wavelength range and pulse energy range as the predicate device.

Nonclinical Performance Data: None

Clinical Performance Data: None

NOV 2 1 2006

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Conclusion: The Greenton Ecolite IPL System raises no new safety or effectiveness questions in comparison to the predicate device.

Additional Information: None

1. 1

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2006

Greenton (London) Ltd % Handren Associates, Inc. Robert T. Handren, Jr., M.S. President 5818 Princess Caroline Place Leesburg, Florida 34748

Re: K062721

Trade/Device Name: Greenton Ecolite IPL 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: September 2, 2006 Received: September 12, 2006

Dear Mr. Handren:

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 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

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Page 2 - Robert T. Handren, Jr., M.S.

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.

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 device 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson 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

510(k) Number (if known): K 062721

Device Name: Greenton Ecolite IPL System

Indications For Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number
1062727Page 1 of 1

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.