(19 days)
Not Found
Not Found
No
The description focuses on the physical characteristics and laser technology, with no mention of AI or ML.
Yes
The device is indicated for hair removal and benign vascular lesion removal applications, which are therapeutic interventions.
No
Explanation: The device description and intended uses clearly state that the M2 Laser is for hair removal and benign vascular lesion removal applications, which are therapeutic rather than diagnostic. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description clearly states it is a solid state laser with physical dimensions, weight, and electrical requirements, indicating it is a hardware device.
Based on the provided information, the M2 Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "hair removal application" and "benign vascular lesion removal applications." These are therapeutic and cosmetic procedures performed directly on the patient's body.
- Device Description: The description details a laser system designed to emit light for these procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples taken from the human body to aid in diagnosis, monitoring, or screening. The M2 Laser's function is to deliver energy to tissue for therapeutic or cosmetic purposes.
N/A
Intended Use / Indications for Use
The M2 Laser is indicated for hair removal and benign vascular lesion removal applications.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The M2 Laser 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
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 (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.
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 | 8 2000
1c994427
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: | Cynosure M2 Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Apogee Laser |
| Device Description: | The M2 Laser 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 M2 Laser is indicated for hair removal application. |
| Comparison: | The M2 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 M2 Laser is another safe and effective device for dermatological
application, specifically hair removal. |
| Additional Information: | None |
:
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized birds in flight.
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
K994427 Re:
Trade Name: Cynosure M2 Laser 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.
Stupt Rhodes
James E. Dillard III 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):
Device Name: _ Cynosure M2 Laser
Indications For Use:
The M2 Laser is indicated for hair removal and benign vascular lesion removal applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stut Rhodes
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K994427
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
.
(Optional Format 1-2-96)