(112 days)
None
Not Found
No
The summary describes a phototherapy system based on a XeCl excimer gas lamp and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the treatment of various medical conditions (leukoderma, psoriasis, vitiligo, eczema, and seborrheic dermatitis), which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a phototherapy system indicated for the treatment of various skin conditions. It uses a light source to deliver therapy, not to diagnose. There is no mention of it collecting data or analyzing any patient information for diagnostic purposes.
No
The device description clearly outlines physical hardware components including a gas lamp, handpiece, and specific dimensions and weight, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the treatment of various skin conditions (leukoderma, psoriasis, vitiligo, eczema, and seborrheic dermatitis). IVDs are used for the diagnosis or monitoring of diseases or conditions by examining samples taken from the human body (like blood, urine, tissue).
- Device Description: The description details a phototherapy system that emits light directly onto the skin. This is a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on samples, or providing diagnostic information based on sample analysis.
Therefore, the Excilite and Excilite μ phototherapy systems are therapeutic devices, not IVDs.
N/A
Intended Use / Indications for Use
The Excilite and Excilite μ systems are indicated for the treatment of leukoderma, psoriasis, vitiligo, eczema, and seborrheic dermatitis.
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.
Product codes
FTC
Device Description
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.
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)
BClear phototherapy system
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY - 5 2005
510(K) Summary
so080
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior 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.
FTC
21 CFR 878.4630 |
| Equivalent Device: | BClear phototherapy system |
| Device Description: | 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. |
| Intended Use: | The Excilite and Excilite μ systems are indicated for the treatment of
leukoderma, psoriasis, vitiligo, eczema, and seborrheic dermatitis. |
| Comparison: | The Excilite and Excilite μ systems have an identical indication for
uses, the same principle of operation, and essentially the same
wavelength 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 the
treatment of leukoderma, psoriasis, vitiligo, eczema, and seborrheic
dermatitis. |
| Additional Information: | none |
1
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.
2
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
3
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__________________________________________________________________________________________________________________________________________________________