(356 days)
The PhotoSilk Plus Pulsed Light System is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.
The PhotoSilk Plus Pulsed Light System Laser Attachment is intended for: Er: Y AG 2,940 mm - for skin resurfacing and for the incision, ablation or vaporization of soft bodily tissues.
Long Pulse Nd: Y AG 1,064 nm - for the treatment of vascular lesions, pigmented lesions, wrinkles and for permanent hair reduction ..
Q-Switched Nd: Y AG 1,064 nm - for dark tattoo removal, and the treatment of pigmented lesions.
The PhotoSilk Plus Pulsed Light System and Laser Attachment provides 400-1200nm pulsed light, 2,940nm Er:YAG, 1064nm Nd:YAG and 1064nm Q-Switched Nd:YAG wavelengths. Laser emission activation is by foot switch. Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.
The provided text is a 510(k) summary for the Cynosure PhotoSilk Plus Pulsed Light System and Laser Attachment. It explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
Therefore, based on the provided document:
- A table of acceptance criteria and the reported device performance: Not applicable. No performance data or acceptance criteria are provided.
- 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 test set data is provided.
- 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 ground truth establishment for a test set is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method is mentioned.
- 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. No MRMC study or AI assistance is mentioned as this device is a medical laser system, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system and does not involve algorithms or standalone performance testing in this context.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is mentioned.
- The sample size for the training set: Not applicable. No training set is mentioned.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is mentioned.
Conclusion: The 510(k) submission for the Cynosure PhotoSilk Plus Pulsed Light System and Laser Attachment did not include any nonclinical or clinical performance data. The device's substantial equivalence was based on its similarity to predicate devices in terms of indications for use, principle of operation, and similar performance specifications, rather than new performance data with acceptance criteria.
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| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, ΜΑ 01824 | 510(K) Summary |
|---|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology | K051442 |
| Date Summary Prepared: | June 1, 2005 | |
| Device Trade Name: | PhotoSilk Plus Pulsed Light System and Laser Attachment | |
| Common Name: | Pulsed Light System.Laser: Er:YAG laser, Nd:YAG laser, Q-Switched Nd:YAG laser. | |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.4810 | |
| Equivalent Device: | StarLux Pulsed Light System, CO3 Er:YAG laser, ESC Nd:YAGAccessory, and Medlite C6 Q-Switched Nd:YAG laser | |
| Device Description: | The PhotoSilk Plus Pulsed Light System and Laser Attachmentprovides 400-1200nm pulsed light, 2,940nm Er:YAG, 1064nmNd:YAG and 1064nm Q-Switched Nd:YAG wavelengths. Laseremission activation is by foot switch. Electrical requirement is 220VAC, 20A, 50-60 Hz, single phase. | |
| Intended Use: | The PhotoSilk Plus Pulsed Light System is intended for permanenthair reduction, and the treatment of vascular and pigmented lesions,facial and leg veins, and inflammatory acne.The PhotoSilk Plus Pulsed Light System Laser Attachment is intendedfor:2,940 nm - for skin resurfacing and for the incision, excision, ablationor vaporization of soft bodily tissues.1,064 nm - for treatment of benign cutaneous vascular lesions,pigmented lesions, and hair removal.QS 1,064 nm - for tattoo removal, and the treatment of pigmentedlesions. | |
| Comparison: | The PhotoSilk Plus Pulsed Light System and Laser Attachment havevery similar indications for use, the same principle of operation, andsimilar performance specifications as the predicate devices. | |
| Nonclinical Performance Data: | none | |
| Clinical Performance Data: | none | |
| Conclusion: | The PhotoSilk Plus Pulsed Light System and Laser Attachment is asafe and effective device for the indications specified. | |
| Additional Information: | none |
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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2006
Cynosure, Inc. % Mr. George Cho Senior Vice President 5 Carlisle Road Westford, Massachusetts 01886
Re: K051442
Trade/Device Name: Cynosure PhotoSilk Plus Pulsed Light System Laser Attachment 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: February 2, 2006 Received: February 3, 2006
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 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 - Mr. George Cho
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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): _ K ( ( 5 | 4 2
Device Name: Cynosure PhotoSilk Plus Pulsed Light System Laser Attachment
Indications For Use:
The PhotoSilk Plus Pulsed Light System is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.
The PhotoSilk Plus Pulsed Light System Laser Attachment is intended for: Er: Y AG 2,940 mm - for skin resurfacing and for the incision, ablation or vaporization of soft bodily tissues.
Long Pulse Nd: Y AG 1,064 nm - for the treatment of vascular lesions, pigmented lesions, wrinkles and for permanent hair reduction ..
Q-Switched Nd: Y AG 1,064 nm - for dark tattoo removal, and the treatment of pigmented lesions.
Prescriptive Use x OR (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.m.de
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Kos1442 510(k) Number.
§ 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.