(10 days)
The Cynosure CO3 Er: YAG Laser is used for skin resurfacing, and for the incision, excision, ablation or vaporization of soft bodily tissues.
Typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.
The CO3 Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench.
This submission is a 510(k) summary for the Cynosure CO3 Er:YAG Laser, which was cleared on September 10, 1998. The document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None".
Therefore, based solely on the provided information, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria, as no such data was submitted or reviewed for this clearance.
The clearance was based on substantial equivalence to a predicate device (Cynosure PhotoGenica ER Laser) in terms of treatment wavelength, pulse duration, pulse energy, and biological effects, implying that the predicate device's prior clearance and established safety/effectiveness served as the basis.
To answer your request based on the absence of this information in the provided document:
Acceptance Criteria and Study for Cynosure CO3 Er:YAG Laser
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Not applicable based on provided document. The 510(k) summary explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." Therefore, no specific acceptance criteria for performance (e.g., efficacy rates, safety endpoints quantified directly for this device) and corresponding reported device performance values were provided in the submission for independent evaluation of this specific device's clinical or nonclinical performance. Not applicable based on provided document. The 510(k) submission states that the Cynosure CO3 Er:YAG Laser is "substantially equivalent to the Cynosure PhotoGenica ER Laser in terms of treatment wavelength, pulse duration, pulse energy, and biological effects." The reported performance is implicitly that it performs equivalently to the predicate device for its intended use (skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues) based on this substantial equivalence claim and the absence of specific new performance data for the 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 test set data (clinical or nonclinical performance) was submitted for this device. The clearance was based on substantial equivalence without new performance data.
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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 data requiring expert ground truth establishment was submitted.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set data requiring adjudication was submitted.
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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 a laser system, not an AI-assisted diagnostic or imaging system. No MRMC study was conducted or relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No new performance data requiring ground truth was submitted for this device. The basis for clearance was substantial equivalence to a legally marketed predicate device.
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The sample size for the training set:
- Not applicable. No training set for an algorithm was used or described.
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How the ground truth for the training set was established:
- Not applicable. No training set was used or described.
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Қ983034
SEP 1 0 1998
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510(K) Summary
| Submitter: | Cynosure, Inc.10 Elizabeth driveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | August 27, 1998 |
| Device Trade name: | Cynosure CO3 Er: Y AG Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device | Cynosure PhotoGenica ER Laser |
| Device description: | The CO3 Er:YAG Laser consists of threeinterconnected sections: the power supply, thewater cooling system and the optical bench. |
| Intended Use: | Skin resurfacing and for the incision, excisionablation or vaporization of soft bodily tissues. |
| Comparison: | The CO3 Er:YAG Laser is substantiallyequivalent to the Cynosure PhotoGenica ERLaser in terms of treatment wavelength, pulseduration, pulse energy, and biological effects. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Cynosure CO3 Er: Y AG Laser is another safeand effective laser for skin resurfacing and for theincision, excision, ablation or vaporization of softbodily tissues. |
| Additional Information: | None requested at this time. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image. The logo is printed in black ink on a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1998
George Cho Senior Vice President Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K983034 Trade Name: Cynosure CO3 Er:YAG Laser Regulatory Class: II Product Code: GEX Dated: August 27, 1998 Received: August 31, 1998
Dear Mr. Cho:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Cho
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): Je 9 3 3 4
Device Name: Cynosure CO3 Er:YAG Laser
Indications For Use:
The Cynosure CO3 Er: YAG Laser is used for skin resurfacing, and for the incision, excision, ablation or vaporization of soft bodily tissues.
Typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use __
(Division Sign-Off)
(Optional Format 1-2-96)
Division of General Restorative Devices 983034
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.