(19 days)
Cynosure PhotoGenica LPIR
Not Found
No
The description focuses on the physical characteristics and basic functionality of a laser device, with no mention of AI or ML terms, image processing, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for "coagulation of dermatological vascular lesions," which is a therapeutic intervention.
No
The device description and intended use indicate it is an aesthetic laser used for coagulation of dermatological vascular lesions, which is a treatment function, not a diagnostic one. There is no mention of it providing information or analysis for diagnosis.
No
The device description clearly states it is a solid state laser with physical components (alexandrite crystal, handpiece, footswitch, significant weight and dimensions) and electrical requirements, indicating it is a hardware device, not software-only.
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.
- Device Function: The Cynosure PhotoGenica SPIR laser is a therapeutic device that uses laser energy to treat dermatological vascular lesions. It directly interacts with the patient's tissue.
- Lack of Sample Analysis: The provided information does not mention any analysis of biological samples. The device's function is based on delivering laser energy to the skin.
Therefore, based on the intended use and device description, the Cynosure PhotoGenica SPIR laser falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PhotoGenica SPIR is indicated for use in dermatology, specifically cutaneous vascular lesions.
The Cynosure PhotoGenica SPIR laser is indicated for coagulation of dermatological vascular lesions.
Product codes
GEX
Device Description
The PhotoGenica SPIR is a solid state laser, having the alexandrite crystal as the lasing medium. It is a pulsed laser with an invisible wavelength of 755nm and a non-contact handpiece. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x 19"x24" (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.
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)
Cynosure PhotoGenica LPIR
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 18 2000
K994437
510(K) Summary
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | December 29, 1999 |
| Device Trade Name: | PhotoGenica SPIR |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Cynosure PhotoGenica LPIR |
| Device Description: | The PhotoGenica SPIR is a solid state laser, having the alexandrite
crystal as the lasing medium. It is a pulsed laser with an invisible
wavelength of 755nm and a non-contact handpiece. |
| | Laser activation is both by finger switch and footswitch. Overall
weight of the laser is 285lbs, and the size is 44"x 19"x24" (HxWxD). |
| | Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase. |
| Intended Use: | The PhotoGenica SPIR is indicated for use in dermatology,
specifically cutaneous vascular lesions. |
| Comparison: | The PhotoGenica SPIR Laser is substantially equivalent to the
Cynosure Apogee Laser. They are both solid state near infra-red lasers
using alexandrite crystal as their lasing medium. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica SPIR Laser is another safe and effective device for
dermatologic applications. |
| Additional Information: | None |
1
Image /page/1/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a person with outstretched arms, representing health and well-being. The logo is simple and recognizable, conveying the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 18 2000
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
K994437 Re:
Trade Name: Cynosure PhotoGenica SPIR Regulatory Class: II Product Code: GEX Dated: December 29, 1999 Received: December 30,1999
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.
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
2
Page 2 - Mr. George Cho
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,
Styptn Rluvels
E. Dillard III James Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): _ K 99 44 37
Device Name: _ Cynosure PhotoGenica SPIR
Indications For Use:
The Cynosure PhotoGenica SPIR laser is indicated for coagulation of dermatological vascular lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hugh Rhodes
(Division Sign-Off) Division of General Restorative Devices