(59 days)
Not Found
Not Found
No
The device description focuses on the physical characteristics and operational parameters of a laser system, with no mention of AI, ML, image processing, or data-driven decision-making.
Yes
The device is indicated for the "treatment of vascular and pigmented lesions of the skin," which describes a therapeutic purpose.
No
The "Intended Use / Indications for Use" section clearly states that the device is "indicated for the treatment of vascular and pigmented lesions," not for diagnosis. The device description also details its specifications for delivering laser energy for treatment.
No
The device description clearly details hardware components such as a laser system, handpieces, footswitch, and power requirements, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of vascular and pigmented lesions of the skin. IVDs are used to diagnose or monitor conditions by examining samples taken from the body (in vitro).
- Device Description: The description details a laser system designed to deliver energy to the skin for therapeutic purposes. This is consistent with a treatment device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
This device is a therapeutic laser system used for dermatological procedures.
N/A
Intended Use / Indications for Use
The PhotoGenica 532 laser is indicated for the treatment of benign cutaneous vascular and pigmented lesions.
Product codes
GEX
Device Description
The PhotoGenica 532 Laser is a CW, frequency-doubled Nd:YAG laser system with a wavelength at 532 nm. The treatment beam output for the PhotoGenica 532 is 4 watts CW at 532 nm. The aiming beam is provided by 5 mW, 670 nm diode laser. Exposure times for the PhotoGenica 532 (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0 and continuous. Laser activation is by a footswitch. Overall weight of the unit is 25 lb (11 kg). Electrical power requirement is 120/230 VAC ±10%, 5/3 Amps, 50-60 Hz. The system is air-cooled by fans. Accessories available for use with the PhotoGenica 532 include 0.2, 0.5, 0.7, 1.0 and 1.5 mm (spot diameter) handpieces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
American Medical Laser Nuvo-Lase 660 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
:
510(K) Summary FEB 2 7 1998
:
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | December 24, 1997 |
| Device Trade Name: | PhotoGenica 532 Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | American Medical Laser Nuvo-Lase 660 Laser |
| Device Description: | The PhotoGenica 532 Laser is a CW, frequency-doubled Nd:YAG
laser system with a wavelength at 532 nm. The treatment beam output
for the PhotoGenica 532 is 4 watts CW at 532 nm. |
| | The aiming beam is provided by 5 mW, 670 nm diode laser. Exposure
times for the PhotoGenica 532 (in seconds) are 0.02, 0.05, 0.1, 0.25,
0.5, 1.0 and continuous. |
| | Laser activation is by a footswitch. Overall weight of the unit is 25 lb
(11 kg). |
| | Electrical power requirement is 120/230 VAC ±10%, 5/3 Amps, 50-60
Hz. The system is air-cooled by fans. |
| | Accessories available for use with the PhotoGenica 532 include 0.2,
0.5, 0.7, 1.0 and 1.5 mm (spot diameter) handpieces. |
| Intended Use: | The PhotoGenica 532 Laser system is indicated for the treatment of
vascular and pigmented lesions of the skin. |
| Comparison: | The PhotoGenica 532 Laser is substantially equivalent to the Nuvo-
Lase 660 Laser in terms of treatment wavelength, pulse duration,
power, and biological effects. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica 532 Laser is another safe and effective way to treat vascular or pigmented lesions of the skin. |
| Additional Information: | None requested at this time |
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:
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Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in a bold, sans-serif font. The words are arranged on a single line, with "Public" and "Health" being the same size and "Service" being slightly smaller. The text is black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 1998
Mr. George Cho Senior Vice President Cynosure, Incorporated 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re : K974900 Cynosure PhotoGenica 532 Laser Trade Name: Regulatory Class: II Product Code: GEX 1997 Dated: December 24, December 30, 1997 Received:
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 The general controls provisions of the Act 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 Requlations, 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.
Image /page/2/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
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Page 2 - Mr. Cho
This letter will allow you to beqin 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 your 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,
Witten, Ph.D., M.D. Celi a M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: _ Cynosure PhotoGenica 532 Laser
Indications For Use:
The PhotoGenica 532 laser is indicated for the treatment of benign cutaneous vascular and pigmented lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
pcoolfo
(Division Sign-Om)
Division of General Restorative Devices K974900
510(k) Number
Over-The-Counter Use_