(70 days)
Not Found
No
The summary describes a standard IPL system with adjustable parameters and a foot switch activation. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies section is empty, further indicating a lack of complex algorithmic components.
Yes
The device is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels, and treatment of benign pigmented lesions and inflammatory acne, which are all therapeutic treatments.
No
The device is indicated for treatment purposes (hair reduction, photocoagulation, photothermolysis, and treatment of lesions and acne), not for diagnosis.
No
The device description clearly outlines a physical system with hardware components (pulsed light system, handpiece, foot switch, power requirements, weight, and dimensions), indicating it is not a software-only medical device.
Based on the provided information, the Greenton Ecolite IPL System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (permanent hair reduction, treatment of vascular lesions, pigmented lesions, and acne) are all therapeutic or cosmetic procedures performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a light-based system applied externally to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Greenton Ecolite IPL System is a medical device used for external therapeutic and cosmetic applications, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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).
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
Conclusion: The Greenton Ecolite IPL System raises no new safety or effectiveness questions in comparison to the predicate device.
.
:
:
Additional Information: None
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2
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
3
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
4
Indications for Use
510(k) Number (if known): K 062721
Device Name: Greenton Ecolite IPL System
Indications For 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).
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