(10 days)
Not Found
Not Found
No
The summary describes a laser device for tissue ablation and resurfacing, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is used for medical procedures such as skin resurfacing, incision, excision, ablation, or vaporization of soft bodily tissues, which are therapeutic interventions.
No
Explanation: The device description states its use is for skin resurfacing, and for the incision, excision, ablation or vaporization of soft bodily tissues, which are all therapeutic or surgical procedures, not diagnostic.
No
The device description explicitly states it consists of hardware components: a power supply, water cooling system, and optical bench.
No, 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.
- Cynosure CO3 Er: YAG Laser Function: The description clearly states that this device is a laser used for skin resurfacing, incision, excision, ablation, or vaporization of soft bodily tissues. These are all procedures performed directly on the patient's body, not on samples taken from the body.
The intended use and device description confirm that this is a surgical laser used for therapeutic and cosmetic procedures, not for diagnostic testing of biological samples.
N/A
Intended Use / 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.
Product codes
GEX
Device Description
The CO3 Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft bodily tissues
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
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
Cynosure PhotoGenica ER 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.
0
Қ983034
SEP 1 0 1998
:
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510(K) Summary
| Submitter: | Cynosure, Inc.
10 Elizabeth drive
Chelmsford, MA 01824 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior 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, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device | Cynosure PhotoGenica ER Laser |
| Device description: | The CO3 Er:YAG Laser consists of three
interconnected sections: the power supply, the
water cooling system and the optical bench. |
| Intended Use: | Skin resurfacing and for the incision, excision
ablation or vaporization of soft bodily tissues. |
| Comparison: | The 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. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Cynosure CO3 Er: Y AG Laser is another safe
and effective laser for skin resurfacing and for the
incision, excision, ablation or vaporization of soft
bodily tissues. |
| Additional Information: | None requested at this time. |
1
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.
2
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
3
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 -