(135 days)
Not Found
Not Found
No
The summary describes a pulsed light system for treating vascular lesions and does not mention any AI or ML components or capabilities.
Yes.
The device is indicated for the "treatment of benign cutaneous vascular lesions" and uses "optical energy for photocoagulation of vascular lesions," which are therapeutic actions.
No
The device description and intended use clearly state that the PhotoLight System is indicated for the "treatment" of benign cutaneous vascular lesions through photocoagulation, not for diagnosis.
No
The device description explicitly states it is a "pulsed light system" utilizing "optical energy," indicating a hardware component for light emission, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of benign cutaneous vascular lesions." This is a therapeutic application, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The device description states it utilizes "optical energy for photocoagulation of vascular lesions." This describes a treatment mechanism, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description lacks any mention of analyzing samples (like blood, urine, tissue), performing tests on those samples, or providing diagnostic information.
Therefore, the PhotoLight System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PhotoLight System is indicated for the treatment of benign cutaneous vascular lesions.
Product codes
GEX, GEZ, KNS
Device Description
The PhotoLight pulsed light system is a medical device utilizing optical energy for photocoagulation of vascular lesions
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cutaneous
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The PhotoDerm VL by ESC Medical Systems
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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APR 2 9 1998
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510(k) Summary
| Submitter | Cynosure, Inc. 10 Elizabeth Drive Chelmsford, MA 01824 |
|---|---|
| Contact | George Cho Senior Vice President |
| Date Summary Prepared | December 12, 1997 |
| Device Trade Name | PhotoLight System |
| Common Name | High intensity flashlamp system |
| Classification Name | Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810 |
| Equivalent Device | The PhotoDerm VL by ESC Medical Systems |
| Device Description | The PhotoLight pulsed light system is a medical device utilizing optical energy for photocoagulation of vascular lesions |
| Intended Use | For the treatment of benign cutaneous vascular lesions |
| Comparison | The PhotoLight is substantially equivalent to the PhotoDerm VL in terms of treatment parameters used and also the intended uses |
| Nonclinical Performance Data | None |
| Clinical Performance Data | None |
| Conclusion | The PhotoLight System is another safe and effective way to treat vascular lesions |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1998
Mr. George Cho ·Senior Vice President Cynosure, Incorporated 10 Elizabeth Drive 01824 Chelmsford, Massachusetts
Re: K974674 Cynosure PhotoLight Flashlamp Trade Name: Regulatory Class: II Product Code: GEZ and KNS Dated: April 3, 1998 ________________________________________________________________________________________________________________________________________________________ Received: April 6, 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 aqainst 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 requlation 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.
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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 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,
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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510(k) Number (if known): __K97 4674
Device Name: Cynosure PhotoLight System
Indications for Ue:
The PhotoLight System is indicated for the treatment of benign cutaneous vascular lesions.
(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 _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off Division of General Ra 510(k) Numb