(30 days)
,"Cynosure PhotoGenica VLS Laser"
Not Found
No
The summary describes a laser device with standard components (power supply, cooling, optical path) and makes no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is used for the treatment of benign vascular and vascular dependent lesions, indicating a therapeutic purpose.
No
The provided text states the device is "used for the treatment of benign vascular and vascular dependent lesions," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states it consists of hardware components: a power supply, water cooling system, and optical path.
Based on the provided information, the Erasure laser is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of benign vascular and vascular dependent lesions." This describes a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical components of a laser system used for treatment (power supply, cooling system, optical path). It doesn't mention any components related to analyzing biological samples.
- Lack of IVD-related information: The document lacks any mention of:
- Image processing (often used in IVDs for analyzing images of samples).
- AI/DNN/ML (sometimes used in advanced IVDs for data analysis).
- Input Imaging Modality (relevant for IVDs that analyze images).
- Anatomical Site (while some IVDs are site-specific, the lack of other IVD indicators is more significant).
- Performance studies related to diagnostic accuracy (sensitivity, specificity, etc.).
The information provided clearly points to a therapeutic laser device used for treating conditions directly on the patient's body, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The Erasure laser is used for the treatment of benign vascular and vascular dependent lesions.
Product codes
GEX
Device Description
The Erasure Laser consists of three interconnected sections: the power supply, the water cooling system and the optical path.
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
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
Cynosure PhotoGenica VLS 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
JAN 20 1999
Kay 4517
510(K) Summary
Cynosure, Inc. Submitter: 10 Elizabeth Drive Chelmsford, MA 01824 George Cho Contact: Senior Vice President of Medical Technology December 18, 1998 Date Summary Prepared: Erasure Pulse Dye Laser Device Trade Name: Medical Laser System Common Name: Instrument, surgical, powered, laser Classification Name: 79-GEX 21 CFR 878.48 Cynosure PhotoGenica VLS Laser Equivalent Device: The Erasure Laser consists of three interconnected sections: the power Device Description: supply, the water cooling system and the optical path. Benign cutaneous vascular and vascular dependent lesions. Intended Use: The Erasure Laser is substantially equivalent to the Cynosure Comparison: PhotoGenica VLS Laser in terms of treatment wavelengths, pulse duration, pulse energy, and biological effects. Nonclinical Performance Data: None Clinical Performance Data: None The Cynosure Erasure Laser is another safe and effective laser for Conclusion: vascular and vascular dependent lesions. Additional Information: None requested at this time
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image. The image within the circle appears to be an abstract representation of a human figure or a symbol related to health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1999
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K984517
Trade Name: Cynosure Erasure Pulse Dye Laser Regulatory Class: II Product Code: GEX Dated: December 18, 1998 Received: December 21, 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 (OS) 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. George 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 1 of 1
Kapus | 510(k) Number (if known):
Device Name: Cynosure Erasure Pulse Dye Laser
Indications For Use:
The Erasure laser is used for the treatment of benign vascular and vascular dependent lesions.
(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 Devices | |
| 510(k) Number | 4984517 |
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(Optional Format 1-2-96)