(247 days)
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No
The summary describes a pulsed light system with adjustable parameters and handpieces, but there is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, treatment planning, or other functions.
Yes
The device is indicated for the treatment of various medical conditions such as inflammatory acne, cutaneous lesions (warts, scars, striae), and dermatological vascular lesions, which are therapeutic applications.
No
The device is indicated for treatment of various dermatological conditions, such as hair reduction, vascular lesions, pigmented lesions, acne, warts, scars, and striae. It is not described as diagnosing these conditions.
No
The device description clearly indicates it is a physical system with a weight of 110 lbs, dimensions, electrical requirements, and a foot switch for activation, all of which are hardware components.
Based on the provided information, the Quanta System Eterna Giovinezza system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed (permanent hair reduction, treatment of vascular lesions, pigmented lesions, acne, warts, scars, and striae) are all direct treatments applied to the patient's body. IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a pulsed light system with handpieces and a foot switch, consistent with a therapeutic device used for external applications.
- 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 Quanta System Eterna Giovinezza system is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Quanta System Eterna Giovinezza is intended 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 (acne vulgaris).
The Quanta System Eterna Giovinezza 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.
It is also indicated for treatment of inflammatory acne (acne vulgaris) and cutaneous lesions, including warts, scars, and striae.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Quanta System Eterna Giovinezza 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" (LxWxH). Electrical requirement is 110 VAC, 15A, 50 Hz, single phase.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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: .
510(K) Summary
| Submitter: | Quanta System SpA
Via IV Novembre, 116
21058 Solbiate Olona
VA / Italy |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Isabella Carrer
Medical Division Manager |
| Date Summary Prepared: | April 29, 2005 |
| Device Trade Name: | Quanta System Eterna Giovinezza system |
| Common Name: | Pulsed Light system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.4810 |
| Equivalent Device: | Palomar Medical Products, Inc. and Cynosure, Inc. |
| Device Description: | The Quanta System Eterna Giovinezza 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" (LxWxH).
Electrical requirement is 110 VAC, 15A, 50 Hz, single phase. |
| Intended Use: | The Quanta System Eterna Giovinezza is intended 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
(acne vulgaris) |
| Comparison: | The Quanta System Eterna Giovinezza system has similar indications
for use, the same principle of operation, and essentially the same
wavelength range and pulse energy range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Quanta System Eterna Giovinezza system is a safe and effective
device for the indicated uses. |
| Additional Information: | none |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces left and has a curved beak. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 4 2006
Ouanta System, SpA. % George Cho Senior Vice President Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824-4145
Re: K051113
Trade/Device Name: Quanta System Eterna Giovinezza 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: December 2, 2005 Received: December 5, 2005
Dear Mr. Cho:
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
2
Page 2 - Mr. Cho
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chabane Bnehm
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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KO SILIS 5 l (k) Number (if known): __________________________________________________________________________________________________________________________________________________
Device Name: _ Quanta System Eterna Giovinezza systems; Standard, Plus and Compact
Indications For Use:
The Quanta System Eterna Giovinezza system is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, ¡¡hotothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
It is also indicated for treatment of inflammatory acne (acne vulgaris) and cutaneous lesions, including warts, scars, and striae.
Prescriptive Use OR >> (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - C ONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cainbare Budum
(Division Signa
Division of General, Restorative, and Neurological Devices
510(k) Numbe