(25 days)
K/DEN number is not available in the text.
Not Found
No
The summary describes a laser device with different wavelengths for various dermatological and surgical applications. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is described as treating various medical conditions, including benign vascular lesions, benign cutaneous lesions, benign pigmented lesions, wrinkles, and for use in general surgery and dermatology for incision, excision, ablation, vaporization, coagulation, and hemostasis of soft tissue, all of which fall under therapeutic uses.
No
Explanation: The provided text describes the Cynosure YAG MIR II laser as a device for treating various benign vascular and cutaneous lesions, wrinkles, and for general surgical procedures like incision, excision, ablation, vaporization, coagulation, and hemostasis of soft tissue. These are all described as treatments or interventions, not diagnostic functions. There is no mention of the device being used to identify, detect, or diagnose diseases or conditions.
No
The device description clearly states it is a physical laser system with a specific weight, dimensions, and electrical requirements, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cynosure YAG MIR II laser is a therapeutic device that uses laser energy to directly treat various conditions on the human body, such as vascular lesions, pigmented lesions, wrinkles, and soft tissue. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes direct treatment of anatomical sites and conditions on the patient.
- Device Description: The description focuses on the physical characteristics and power requirements of a laser system used for direct application.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
1064nm: The Cynosure YAG MIR II 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 lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), Café au lait macules, 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.
1320mm: The Cynosure YAG MIR II laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of perioral and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.
1440nm: The Cynosure YAG MIR II laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles and pigmented lesions.
Product codes
GEX
Device Description
The Cynosure YAG MIR II laser is a Nd: Y AG laser, having a ND:YAG crystal rod as a lasing medium. Laser activation is by footswitch or finger switch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD). Electrical requirement is 220 VAC, 30A, 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 The Cynosure Y AG MIR II Laser is a safe and effective device for the Conclusion: indications specified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cynosure YAG Family laser, Cynosure YAG MIR Family laser
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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510(K) Summary Submitter: Cynosure, Inc. 5 Carlisle Road JAN 3 0 2007 Westford, MA 01886 George Cho Contact: Senior Vice President of Medical Technology Date Summary Prepared: January 4, 2007 Cynosure YAG MIR II Laser Device Trade Name: Medical Laser System Common Name: Instrument, surgical, powered, laser Classification Name: 79-GEX 21 CFR 878.4810 Cynosure YAG Family laser, Cynosure YAG MIR Family laser Equivalent Device: The Cynosure Y AG MIR II laser is a Nd: Y AG laser, having a Device Description: ND:YAG crystal rod as a lasing medium. Laser activation is by footswitch or finger switch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase. The Cynosure YAG MIR II Laser is indicated for the treatment of Intended Use: vascular and pigmented lesions and wrinkles. The Cynosure Y AG MIR II Laser has the same indications for use, the Comparison: same principle of operation, and same wavelengths and pulse energy range as the predicate device(s). Nonclinical Performance Data: none Clinical Performance Data: none The Cynosure Y AG MIR II Laser is a safe and effective device for the Conclusion: indications specified. Additional Information: none
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three overlapping shapes that resemble human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2007
Cynosure Incorporated % Mr. George Cho Senior Vice President 5 Carlisle Road Westford, Massachusetts 01886
Re: K070063
Trade/Device Name: CynosureYAG MIR II Laser Regulation Number: 21 CFR 878.4810. Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Regulatory Class: Class II Product Code: GEX Dated: January 4, 2007 Received: January 8, 2007
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For
Mark N. Mellon
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):
Device Name: Cynosure YAG MIR II Laser
Indications For Use:
1064nm: The Cynosure YAG MIR II 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 lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), Café au lait macules, 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.
1320mm: The Cynosure YAG MIR II laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of perioral and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.
1440nm: The Cynosure YAG MIR II laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles and 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurolo al Devices
510(k) Nur. | 160063