(29 days)
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 leg veins, indicated for photocoagulation of and the treatment of benign pigmented lesions.
The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal effects and discomfort associated with light applications.
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.
The provided document is a 510(k) summary for the Photosilk and Photosilk Plus intense pulsed light systems, filed in 2004. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness based on new clinical studies with defined acceptance criteria.
Therefore, the document does not contain the requested information regarding acceptance criteria for device performance, or details of a study designed to prove the device meets such criteria. Specifically, the "Nonclinical Performance Data" and "Clinical Performance Data" sections explicitly state "none."
The summary indicates that the device's equivalence is based on having the "same principle of operation, the same wavelength and essentially the same power range as the predicate device for the same indications for uses." This means its acceptance stemmed from a comparison to a previously cleared device, not from an independent study demonstrating specific performance metrics against pre-defined acceptance criteria.
Response to Specific Questions based on the provided document:
-
A table of acceptance criteria and the reported device performance:
Not applicable. The document does not define specific performance acceptance criteria for the Photosilk/Photosilk Plus, nor does it report performance data from a study against such criteria. The device's acceptance is based on substantial equivalence to a predicate device. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No new clinical or non-clinical performance data (test set) was presented for this 510(k) submission. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No test set requiring expert ground truth was described. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set requiring adjudication was described. -
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. This device is an intense pulsed light system, not an AI-driven diagnostic or assistive tool. No MRMC study was mentioned. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an intense pulsed light system, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No new clinical study was conducted. -
The sample size for the training set:
Not applicable. This device relies on substantial equivalence, not a machine learning model that requires a training set. -
How the ground truth for the training set was established:
Not applicable. This device relies on substantial equivalence, not a machine learning model.
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MAY 2 6 2004
510(K) Summary
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior 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, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Photolight PL system |
| Device Description: | Photosilk and Photosilk Plus are intense pulsed light systems, having aXenon flashlamp located in the handpieces. It is a light source with awavelength range of approximately 400 - 1200nm.Light emission activation is by foot switch. Overall weight of the laseris 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 thatcontains cooled water circulated through the handpiece body, the faceof which is in contact with the skin. |
| Intended Use: | The Photosilk and Photosilk Plus systems are indicated for permanenthair reduction, and the treatment of benign vascular and pigmentedlesions. |
| Comparison: | The Photosilk and Photosilk Plus are substantially equivalent to thePhotolight PL, with the same principle of operation, the samewavelength and essentially the same power range as the predicatedevice 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 devicefor permanent hair reduction, and treatment of benign vascular andpigmented lesions. |
| Additional Information: | none |
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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.
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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 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
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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
§ 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.