← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K101601 # AFFIRM DO DIODE LASER (K101601) _Cynosure, Inc. · GEX · Sep 23, 2010 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K101601 ## Device Facts - **Applicant:** Cynosure, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Sep 23, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## 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. ## Device Story Affirm DO is a 1440 nm diode laser system used in general surgery and dermatology. Device operates via footswitch activation to deliver laser energy for soft tissue coagulation and treatment of perioral wrinkles and pigmented lesions. System is compact (25 x 9 x 18 cm), weighs 15 kg, and requires 115 VAC power. Operated by clinicians in a clinical setting. Output is laser energy; clinical benefit is achieved through tissue coagulation and dermatological treatment. ## Clinical Evidence No clinical data provided; no nonclinical performance data provided. ## Technological Characteristics Diode laser; 1440 nm wavelength; footswitch-activated; 15 kg weight; 25 x 9 x 18 cm dimensions; 115 VAC, 15A, 50-60 Hz power requirement. ## Regulatory 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. ## Predicate Devices - Cynosure YAG MIR Family Laser ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K101601](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K101601) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com