(112 days)
The Excilite and Excilite μ phototherapy systems are indicated for the treatment of leukoderma, psoriasis, vitiligo, eczema, and seborrheic dermatitis, for skin types I to VI.
Excilite and Excilite-μ phototherapy systems have a XeCl excimer gas lamp located in the handpiece. It is a light source with a range approximately 306 - 310 nm wavelength. Emission activation is by finger switch. Overall weight of the laser is 19 Kg, and the size is 50x38x24 cm (HxWxD). Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The provided text is a 510(k) summary and an FDA clearance letter for the Excilite and Excilite μ phototherapy systems. These documents primarily focus on demonstrating substantial equivalence to a predicate device for market clearance, rather than presenting a performance study with acceptance criteria.
Specifically:
- The "Nonclinical Performance Data" and "Clinical Performance Data" sections in the 510(k) summary both state "none." This indicates that no specific performance studies (clinical or non-clinical) were submitted or summarized for this device to establish new acceptance criteria.
- The FDA letter confirms that the device was cleared based on its substantial equivalence to a legally marketed predicate device, not on meeting new performance criteria from an independent study.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
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MAY - 5 2005
510(K) Summary
so080
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | January 12, 2005 |
| Device Trade Name: | Excilite and Excilite μ |
| Common Name: | Narrow band ultraviolet phototherapy equipment |
| Classification Name: | Ultraviolet lamp for dermatology disorders.FTC21 CFR 878.4630 |
| Equivalent Device: | BClear phototherapy system |
| Device Description: | Excilite and Excilite-μ phototherapy systems have a XeCl excimer gaslamp located in the handpiece. It is a light source with a rangeapproximately 306 - 310 nm wavelength. |
| Emission activation is by finger switch. Overall weight of the laser is19 Kg, and the size is 50x38x24 cm (HxWxD). | |
| Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. | |
| Intended Use: | The Excilite and Excilite μ systems are indicated for the treatment ofleukoderma, psoriasis, vitiligo, eczema, and seborrheic dermatitis. |
| Comparison: | The Excilite and Excilite μ systems have an identical indication foruses, the same principle of operation, and essentially the samewavelength range and pulse energy range as the predicate device. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Excilite and Excilite μ are both safe and effective devices for thetreatment of leukoderma, psoriasis, vitiligo, eczema, and seborrheicdermatitis. |
| Additional Information: | none |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2005
Mr. George Cho Senior Vice President Cynosure Incorporated 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K050080
Trade/Device Name: Cynosure Excilite and Excilite μ Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: March 23, 2005 Received: March 24, 2005
Dear Mr. Cho:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary to regars) the Medical Device Amendments, or to Conninered pror to May 20, 1978, ac econdance with the provisions of the Federal Food, Drug, de vices frat have been require approval of a premarket approval application (PMA). alla Costietle rearly rece the device, subject to the general controls provisions of the Act. The r ou may, merelore, market of the Act include requirements for annual registration, listing of general controls provision gractice, 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 It may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Ovaouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Drissaanse over device complies with other requirements of the Act mar i Dri has made a and regulations administered by other Federal agencies. You must of any rederal statutes and regulations ancluding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, n.c. and 801); good manufacturing practice requirements as set CITY art 807), adoling (21 OFF Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. George Cho
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manieting of substantial equivalence of your device to a legally premarket notification: "The PDF interestion 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 If you desire specific acrice for Jour acon 15 . Also, please note the regulation entitled, Comaci une Office of Computation (21 to the end 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consailer ribersanter in the many support/index.html.
Sincerely yours,
Elen Olen, M
Miriam C. Provost, Ph.D. Acting 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): _ K OS O O D D D
Device Name: _Cynosure Excilite and Excilite u
Indications For Use:
The Excilite and Excilite u phototherapy systems are indicated for the treatment of leukoderma, Frie Enomitiigo, eczema, and seborrheic dermatitis, for skin types I to VI.
Prescriptive Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dan C. Adkins
050010
Prescription Use_X
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.