(107 days)
Cynosure YAG MIR Family Laser
Not Found
No
The summary describes a standard diode laser device with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The device is indicated for the treatment of perioral wrinkles and pigmented lesions, which constitutes a therapeutic use.
No
The device is described as a laser indicated for the coagulation of soft tissue, treatment of perioral wrinkles, and pigmented lesions in general surgery and dermatology. Its function is therapeutic (treatment/coagulation), not diagnostic.
No
The device description clearly indicates it is a physical laser device with specified weight, dimensions, and electrical requirements, activated by a footswitch. This is not a software-only device.
Based on the provided information, the Affirm DO Diode laser device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- The Affirm DO Diode laser device is used directly on the patient's body for surgical and dermatological procedures (coagulation of soft tissue, treatment of wrinkles and pigmented lesions).
The description clearly indicates a device used for therapeutic and cosmetic treatments performed in vivo (on a living organism), not for analyzing samples in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
The Affirm DO is indicated for use in general surgery and dermatology for the coagulation of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles, and pigmented lesions.
Product codes
GEX
Device Description
Affirm DO is a diode laser. It is a laser with a wavelength of 1440 nm. Laser activation is by footswitch. Overall weight of the laser is 15 Kg, and the size is 25 x 9 x 18 cm (HxWxD). Electrical requirement is 115 VAC, 15A, 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
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics
Not Found
Predicate Device(s)
Cynosure YAG MIR Family 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
区101601
510(K) Summary
SEP 2 3 2010
:
| Submitter: | Cynosure, Inc.
5 Carlisle Road
Westford, MA 01886 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Anthony Burns
Director of Regulatory Affairs |
| Date Summary Prepared: | June 2, 2010 |
| Device Trade Name: | Affirm DO Diode Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, Surgical, Powered, Laser
79-GEX
21 CFR 878.4810 |
| Equivalent Device: | Cynosure YAG MIR Family Laser |
| Device Description: | Affirm DO is a diode laser. It is a laser with a wavelength of 1440 nm. |
| | Laser activation is by footswitch. Overall weight of the laser is 15 Kg,
and the size is 25 x 9 x 18 cm (HxWxD). |
| | Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The Affirm DO is indicated for use in general surgery and dermatology
for the coagulation of soft tissue. It is also indicated for the treatment
of periorbital and perioral wrinkles, and pigmented lesions. |
| Comparison: | TheAffirm DO Diode laser has the same indication for uses, the same
principle of operation, the same wavelength and similar pulse energy
range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Affirm DO Diode laser is a safe and effective device for the
intended uses. |
| Additional Information: | none |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cynosure, Inc. % Mr. Anthony Burns Director of Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886
SEP 2 3 2010
Re: K101601
Trade/Device Name: Affirm DO Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 09, 2010 Received: September 20, 2010
Dear Mr. Burns:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Anthony Burns
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours. Mark N. Melkerson
· Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
SEP 2 3 2010
Device Name: | Affirm DO Diode Laser
Indications For Use:
The Affirm DO Diode laser device is indicated for use in general surgery and dermatology for the coagulation of soft tissue. It is also indicated for the treatment of perioral wrinkles, and pigmented lesions.
ಗ Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Andersen Forman
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101601