(167 days)
Not Found
Not Found
No
The summary describes a standard pulsed laser device with no mention of AI or ML components, image processing, or performance studies related to algorithmic analysis.
Yes
The device is indicated for benign vascular lesions and hair removal, which are treatments aimed at addressing or correcting a health condition or physical characteristic.
No
The device description indicates it is a laser used for treatment (benign vascular lesions and hair removal), not for diagnosis. There is no mention of it providing information to diagnose a condition.
No
The device description clearly indicates it is a physical laser system with a specific weight, dimensions, and electrical requirements, not a software-only device.
Based on the provided information, the Derma YAG Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for treating benign vascular lesions and hair removal. These are procedures performed directly on the patient's body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a laser system designed for delivering energy to tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any aspects related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Derma YAG Laser's function is therapeutic and cosmetic, not diagnostic.
N/A
I'm sorry, I cannot fulfill that request. The provided text does not contain enough information to extract the requested details about "Mentions image processing", "Mentions AI, DNN, or ML", "Input Imaging Modality", "Anatomical Site", "Indicated Patient Age Range", "Intended User / Care Setting", "Description of the training set", "Description of the test set", "Summary of Performance Studies", "Key Metrics", and "Predetermined Change Control Plan (PCCP)".
Intended Use / Indications for Use
The Derma YAG Laser is indicated for benign vascular lesions and hair removal.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Derma YAG Laser is a pulse Nd:YAG laser utilizing the Nd:YAG crystal as the lasing medium. It is a pulsed laser with a wavelength of 1064nm.
Laser activation is by a footswitch. Overall weight of the laser is 63 kg, and the size is 80 cm x 42 cm x 80 cm (H x W x D).
Electrical requirement is 220VAC, 12A, 50-60 Hz, single phase.
Mentions image processing
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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 (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.)
Not Found
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.
Smartepil Laser
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.
0
510(K) Summary
.
| Submitter: | El.En. S.p.A.
via Baldanzese, 17
50041 Calenzano (FI), Italy |
|------------------------|--------------------------------------------------------------------|
| Contact: | Andrea Tozzi
Quality System Manager & Official Correspondent |
| Date Summary Prepared: | September 5, 2006 |
MAR 01 2007
| Device Trade Name: | Derma YAG |
|---|---|
| Common Name: | Dermatology Laser |
| Classification Name: | Instrument, surgical, powered, laser |
| 79-GEX | |
| 21 CFR 878.4810 | |
| Equivalent Device: | Smartepil Laser |
| Device Description: | The Derma YAG Laser is a pulse Nd:YAG laser utilizing the |
| Nd:YAG crystal as the lasing medium. It is a pulsed laser with | |
| a wavelength of 1064nm. |
Laser activation is by a footswitch. Overall weight of the laser
is 63 kg, and the size is 80 cm x 42 cm x 80 cm
(H x W x D).
Electrical requirement is 220VAC, 12A, 50-60 Hz, single
phase. |
| Intended Use: | The Derma YAG Laser is indicated for benign vascular
lesions and hair removal. |
| Comparison: | The Derma YAG Laser is substantially equivalent to the
Cynosure Smartepil Laser. They are both pulse Nd:YAG lasers
for the identical indications for use. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Derma YAG Laser is another safe and effective device for
dermatological vascular lesions and hair removal. |
| Additional Information: | None |
:
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol that resembles a stylized caduceus, a traditional symbol of medicine, with three diagonal lines above it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
El.En.S.p.A. % Ms. Andrea Tozzi Quality System Manager and Official Correspondent Via Baldanzese, 17 50041 Calenzano (FI), Italy
MAR 0 1 2007
Re: K062762
Trade/Device Name: Derma YAG 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: January 10, 2007 Received: January 12, 2007
Dear Ms. Tozzi:
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 - Ms. Andrea Tozzi
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. product radiance for begin marketing your device as described in your Section 510(k) rran reket 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 A. Millerman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(K) Number (if known): _ KO (27 b 2
Device Name: _________ Derma YAG
Indications For Use:
The Derma YAG Laser is indicated for benign vascular lesions and hair removal.
Prescriptive Use (Part 21 CFR 801 Subpart D) Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
1062762
(Optional Format 1-2-96)