(356 days)
StarLux Pulsed Light System, CO3 Er:YAG laser, ESC Nd:YAG Accessory, Medlite C6 Q-Switched Nd:YAG laser
Not Found
No
The summary describes a pulsed light and laser system with various wavelengths for dermatological treatments. There is no mention of AI, ML, image processing, or any data-driven algorithms that would indicate the use of these technologies. The device description focuses on the physical characteristics and functionalities of the light and laser emissions.
Yes
The device is intended for the treatment of various medical conditions, including dermatological vascular lesions, benign pigmented lesions, and inflammatory acne, which are therapeutic applications. Additionally, it is used for skin resurfacing and the incision, ablation, or vaporization of soft bodily tissues.
No
The device is intended for treatment purposes such as hair reduction, treatment of vascular and pigmented lesions, skin resurfacing, and tissue incision/ablation, not for diagnosing conditions.
No
The device description clearly indicates it is a hardware system emitting pulsed light and laser wavelengths, requiring electrical power and activated by a foot switch. It does not mention any software-only components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to treating conditions on or within the body (hair reduction, vascular lesions, skin resurfacing, tissue incision/ablation, tattoo removal, wrinkle treatment). IVDs are used to diagnose conditions by examining samples taken from the body (like blood, urine, tissue).
- Device Description: The device description details wavelengths of light and laser used for therapeutic purposes, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The PhotoSilk Plus Pulsed Light System and Laser Attachment is a therapeutic device that uses light and laser energy to treat various dermatological and soft tissue conditions.
N/A
Intended Use / Indications for Use
The PhotoSilk Plus Pulsed Light System is intended for permanent hair 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 intended for:
2,940 nm - for skin resurfacing and for the incision, excision, ablation or 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 pigmented lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
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.
StarLux Pulsed Light System, CO3 Er:YAG laser, ESC Nd:YAG Accessory, and Medlite C6 Q-Switched Nd:YAG laser
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
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| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, ΜΑ 01824 | 510(K) Summary |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Contact: | George Cho
Senior 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, laser
79-GEX
21 CFR 878.4810 | |
| Equivalent Device: | StarLux Pulsed Light System, CO3 Er:YAG laser, ESC Nd:YAG
Accessory, and Medlite C6 Q-Switched Nd:YAG laser | |
| Device Description: | 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. | |
| Intended Use: | The PhotoSilk Plus Pulsed Light System is intended for permanent
hair 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 intended
for:
2,940 nm - for skin resurfacing and for the incision, excision, ablation
or 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 pigmented
lesions. | |
| Comparison: | The PhotoSilk Plus Pulsed Light System and Laser Attachment have
very similar indications for use, the same principle of operation, and
similar 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 a
safe and effective device for the indications specified. | |
| Additional Information: | none | |
:
1
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
2
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
3
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.