(91 days)
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No
The document describes a laser device with different wavelengths for various dermatological treatments. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The device description focuses on the physical characteristics and laser capabilities.
Yes
The device is intended for the removal of benign vascular and cutaneous lesions, treatment of wrinkles, and hair removal, which are therapeutic applications.
No
The provided text describes the Cynergy laser as a device intended for the removal and treatment of various benign lesions, wrinkles, and unwanted hair. It outlines different applications based on wavelengths and includes device description, but there is no mention of it being used for diagnosis or obtaining diagnostic information about a patient's condition. Its purpose is therapeutic and cosmetic.
No
The device description clearly outlines a physical laser system with specific wavelengths, a footswitch for activation, significant weight and dimensions, and electrical requirements, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cynergy laser is a medical device that uses laser energy to treat various skin conditions and remove unwanted hair. It directly interacts with the patient's body (in vivo) rather than analyzing samples taken from the body (in vitro).
- Intended Use: The intended uses listed are all related to direct treatment of the patient's skin and hair, not the analysis of biological samples.
Therefore, the Cynergy laser falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cynergy Multiplex is indicated for treatment of vascular lesions, pigmented lesions, tattoos, wrinkles and hair removal.
585 - 600nm: The Cynergy laser is indicated for benign vascular and vascular dependant lesions removal.
1,064nm: The Cynergy laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Additionally, the laser is intended for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB).
585 - 600nm with 1,064mm Wavelength Multiplex Mode: The wavelength multiplex mode is intended for benign vascular and vascular dependant lesions removal.
Product codes (comma separated list FDA assigned to the subject device)
79-GEX, 79GEX
Device Description
The Cynergy Multiplex laser is user selectable, multi wavelength laser, having both an organic dye and an Nd:YAG rod lasing medium. It is a pulsed dye laser with wavelengths of 585, 590, 595, 600 nm and an Nd:YAG laser with a wavelength of 1,064 nm. It is capable of delivering one wavelength pulse or mixing of two wavelengths pulse.
Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD).
Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.
The system is a user selectable, multi-wavelength laser including both an organic dye ND ND: YAG rod lasing medium. It is capable of delivering one wavelength pulse or a combination of two wavelength pulses (PDL followed by Nd: YAG).
Wavelength in Nanometers: 1064; 585, 590, 595 & 600; capable of mixing two wavelengths.
Power/Energy Range (Watts/Joules): max 25 J/cm² (PDL); 300 J/cm² (Nd:YAG)
Pulse Width: 0.5-40 ms (PDL); 0.5-300 ms (Nd: YAG)
Repetition Rate: Single: 1-2 Hz (PDL); 1-10 Hz (Nd:YAG)
Delivery System: Single optical fiber (lens-coupled quartz), one for each head, and hand pieces with spot sizes ranging from 4.8-12.3 mm (PDL) or 2.8-15.3 mm (Nd:YAG)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
Cynosure Cynergy 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.
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JUN 27 2005
JUN 27 2005
:
510(K) Summary
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | March 25, 2005 |
| Device Trade Name: | Cynergy Multiplex Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Cynosure Cynergy laser |
| Device Description: | The Cynergy Multiplex laser is user selectable, multi wavelength laser,
having both an organic dye and an Nd:YAG rod lasing medium. It is a
pulsed dye laser with wavelengths of 585, 590, 595, 600 nm and an
Nd:YAG laser with a wavelength of 1,064 nm. It is capable of
delivering one wavelength pulse or mixing of two wavelengths pulse.
Laser activation is by footswitch. Overall weight of the laser is 285lbs,
and the size is 44"x19"x24" (HxWxD).
Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single
phase. |
| Intended Use: | The Cynergy Multiplex is indicated for treatment of vascular lesions,
pigmented lesions, tattoos, wrinkles and hair removal. |
| Comparison: | The Cynergy Multiplex laser is substantially equivalent to the predicate
laser with the same principle of operation, and similar wavelengths and
fluence ranges as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Cynergy Multiplex laser is another safe and effective device for
treating vascular lesions, pigmented lesions, tattoos, wrinkles and hair
removal. |
| Additional Information: | none |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 27 2005
Mr. George Cho Senior Vice President Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K050779
Trade/Device Name: Cynosure Cynergy Laser 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: March 25, 2005 Received: March 28, 2005
Dear Mr. Cho:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 too stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, de necs mat have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (Act) that do not requent openeral controls provisions of the Act. The r ou may, mercrore, market the act include requirements for annual registration, listing of gencial controls provisions of the fiel 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 your acviec is elassified (660 ac v) strols. Existing major regulations affecting your device and It may be subject to sadh additions, Title 21, Parts 800 to 898. In addition, FDA can oc found in the Oods of reasureming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc devised that I Dri brosams of your device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must or any it call the Act's requirements, including, but not limited to: registration and listing (21 comply will an the 110 - 11 CFR Part 801); good manufacturing practice requirements as set CI It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byevens (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 ms icter will anow you to oogin maing of substantial equivalence of your device to a legally premarket notification: "The Pels 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 If you desire specific acries in 1 2 = 0 15 . Also, please note the regulation entitled, Connect the Office of Course 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/industry/support/index.html.
Sincerely yours,
Signature
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
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Name of Manufacturer: Cynosure, Inc.
Laser Model Name and Number: CYNERGY MULTIPLEX LASER for surgery and dermatology.
Laser Type: (Circle all that apply) Laser Type. (Onele an alar app.) Diode, Dye Old: YAG, Erbium, Hol:YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other _______________________________________________________________________________________________________________________________
Indications in this application: Treatment of vascular lesions, pigmented lesions, tattoos, wrinkles and hair removal when a single wavelength pulse is delivered. In the multiplex mode, only benign vascular and vascular dependent lesion removals are indicated.
FDA Document Control Number: K050779/A1
FDA Product Code: 79GEX
Reviewer Computer Initials: ABC
Date of Clearance Letter: 6/22/05
Basis of Approval: (Circle all that apply) Dasts of Approval. (Sirely and apply)
Predicate Device (PD) Clinical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Test Data (BTD), Historical Information (HI), Other __________________________________________________________________________________________________________________________
Description of Laser: The system is a user selectable, multi-wavelength laser including both an Deseription of Labor VAG rod lasing medium. It is capable of delivering one wavelength pulse or a combination of two wavelength pulses (PDL followed by Nd: YAG).
Operation-Modes: (Circle all that apply) CW, Pulsed, Q Switched, Mode Locked, Contact, Free Beam, Other _______________________________________________________________________________________________________________
Wavelength in Nanometers: 1064; 585, 590, 595 & 600; capable of mixing two wavelengths.
Power/Energy Range (Watts/Joules): max 25 J/cm² (PDL); 300 J/cm² (Nd:YAG)
Pulse Width: 0.5-40 ms (PDL); 0.5-300 ms (Nd: YAG)
Repetition Rate: Single: 1-2 Hz (PDL); 1-10 Hz (Nd:YAG)
Delivery System: Single optical fiber (lens-coupled quartz), one for each head, and hand pieces with spot sizes ranging from 4.8-12.3 mm (PDL) or 2.8-15.3 mm (Nd:YAG)
Comments: The delay times between two pulses can range from 20-2000 ms. In the absence of new clinical data for multiplex applications, only removal of benign vascular and vasculardependent lesions is indicated for the multiplex mode.
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ Cynosure Cynergy Laser
Indications For Use:
585 - 600nm: The Cynergy laser is indicated for benign vascular and vascular dependant lesions removal.
1,064nm: The Cynergy laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Additionally, the laser is intended for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB).
585 - 600nm with 1,064mm Wavelength Multiplex Mode: The wavelength multiplex mode is intended for benign vascular and vascular dependant lesions removal.
OR Prescriptive Use X 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Vising " Division of Center, I Destrative and Neur Slogical L
050779