(167 days)
The Derma YAG Laser is indicated for benign vascular lesions and hair removal.
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.
The provided 510(k) summary for the Derma YAG Laser (K062762) indicates that no clinical performance data was submitted. Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical outcomes.
The submission relies on demonstrating substantial equivalence to a predicate device (Cynosure Smartepil Laser) for the identical indications for use (benign vascular lesions and hair removal). This means that its safety and effectiveness are established by the predicate's known performance, rather than through new clinical studies for the Derma YAG itself.
Given this, I cannot complete a table of acceptance criteria and reported device performance from the provided text, as no such data is presented. Similarly, answers to the other numbered questions concerning clinical study details are not available in this document.
Here's what can be stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No clinical performance data provided in the 510(k) summary. |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable, as no clinical test set was described.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no clinical test set was described.
4. Adjudication method for the test set
- Not applicable, as no clinical test set was described.
5. 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, as this device is a laser for dermatological procedures and not an AI-assisted diagnostic tool requiring MRMC studies. No comparative effectiveness study of any kind was submitted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this device is a laser for dermatological procedures and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no clinical study or ground truth establishment was described for this device.
8. The sample size for the training set
- Not applicable, as no clinical study involving a training set was described.
9. How the ground truth for the training set was established
- Not applicable, as no clinical study involving a training set or ground truth establishment was described.
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510(K) Summary
.
| Submitter: | El.En. S.p.A.via Baldanzese, 1750041 Calenzano (FI), Italy |
|---|---|
| Contact: | Andrea TozziQuality 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, laser79-GEX21 CFR 878.4810 |
| Equivalent Device: | Smartepil Laser |
| Device Description: | The Derma YAG Laser is a pulse Nd:YAG laser utilizing theNd:YAG crystal as the lasing medium. It is a pulsed laser witha wavelength of 1064nm.Laser activation is by a footswitch. Overall weight of the laseris 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, singlephase. |
| Intended Use: | The Derma YAG Laser is indicated for benign vascularlesions and hair removal. |
| Comparison: | The Derma YAG Laser is substantially equivalent to theCynosure Smartepil Laser. They are both pulse Nd:YAG lasersfor the identical indications for use. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Derma YAG Laser is another safe and effective device fordermatological vascular lesions and hair removal. |
| Additional Information: | None |
:
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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
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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
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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)
§ 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.