(29 days)
Not Found
Not Found
No
The description focuses on the physical characteristics and light-based technology of the device, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section states the device is indicated for permanent hair reduction, and the treatment of benign vascular and pigmented lesions, which are medical treatments.
No
The device descriptions indicate that the Photosilk and Photosilk Plus systems are used for treatment purposes (permanent hair reduction, photocoagulation, treatment of lesions), not for diagnosing conditions.
No
The device description clearly outlines hardware components such as a Xenon flashlamp, handpieces, a foot switch, and a cooling system, indicating it is a physical device, not software-only.
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 Photosilk and Photosilk Plus systems are for permanent hair reduction and the treatment of benign vascular and pigmented lesions. These are all procedures performed directly on the patient's body for therapeutic or cosmetic purposes.
- Device Description: The description details an intense pulsed light system that emits light onto the skin. This is a physical treatment method, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Photosilk and Photosilk Plus systems operate in vivo (on the body) for treatment.
N/A
Intended Use / Indications for Use
The Photosilk and Photosilk Plus systems are indicated for permanent hair reduction, and the treatment of benign vascular and pigmented lesions.
The Photosilk and Photosilk Plus pulsed light system is indicated for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions and photothermolysis of blood vessels and the treatment of benign pigmented lesions.
The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury and discomfort associated with light applications.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Photosilk and Photosilk Plus are intense pulsed light systems, having a Xenon flashlamp located in the handpieces. It is a light source with a wavelength range of approximately 400 - 1200nm. Light emission activation is by foot switch. Overall weight of the laser is 65 Kg, and the size is 103x50x48 cm (HxWxD). Electrical requirement is 220 VAC, 15A, 50-60 Hz, single phase. Skin cooling is provided by the integrated cooling handpiece that contains cooled water circulated through the handpiece body, the face of which is in contact with the skin.
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 (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.
Not Found
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.
Not Found
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).
Not Found
§ 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
MAY 2 6 2004
510(K) Summary
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | April 26, 2004 |
| Device Trade Name: | Photosilk and Photosilk Plus |
| Common Name: | Intense pulsed light system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Photolight PL system |
| Device Description: | Photosilk and Photosilk Plus are intense pulsed light systems, having a
Xenon flashlamp located in the handpieces. It is a light source with a
wavelength range of approximately 400 - 1200nm.
Light emission activation is by foot switch. Overall weight of the laser
is 65 Kg, and the size is 103x50x48 cm (HxWxD).
Electrical requirement is 220 VAC, 15A, 50-60 Hz, single phase.
Skin cooling is provided by the integrated cooling handpiece that
contains cooled water circulated through the handpiece body, the face
of which is in contact with the skin. |
| Intended Use: | The Photosilk and Photosilk Plus systems are indicated for permanent
hair reduction, and the treatment of benign vascular and pigmented
lesions. |
| Comparison: | The Photosilk and Photosilk Plus are substantially equivalent to the
Photolight PL, with the same principle of operation, the same
wavelength and essentially the same power range as the predicate
device for the same indications for uses. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Photosilk and Photosilk Plus are another safe and effective device
for permanent hair reduction, and treatment of benign vascular and
pigmented lesions. |
| Additional Information: | none |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape and features the department's name around the perimeter. In the center of the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2004
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K041095
Trade/Device Name: Photosilk and Photosilk Plus 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: April 26, 2004 Received: April 27, 2004
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 cither 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 madc 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (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 and in Jourse FDA finding of substantial equivalence of your device to a legally premium to hotification. " 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 in you attire of Compliance at (301) 594-4659. 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 other general 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/dsma/dsmamain.html
Sincerely yours,
l. Mark A. Millheusen
Celia M. Witten, Ph.D., M.D. 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):
Device Name: Photosilk and Photosilk Plus pulsed light system
Indications For Use:
The Photosilk and Photosilk Plus pulsed light system is indicated for permanent hair reduction. It is also The Photostik and Photosik I las pulsed itgated as a lesions, photothermolysis of blood vessels
indicated for photocoagulation of dermatological vascular lesions and lovens marcated for photocougatures of and the treatment of benign pigmented lesions.
The integrated cooling handpiece is intended to provide pre-cooling of the epidenmis, to reduce thermal I he illtegrated coomig indicpless is meetieve with and discomfort associated with light applications.
N Prescription Use _ (Part 21 CFR 801 Subpart D) ાર
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milhersan
. Restorative, and Neurological Devices
510(k) Number K091095