AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE

K080006 · Cynosure, Inc. · GEX · Feb 28, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080006
• Device Name: AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1064nm: The Cynosure Affirm Family laser is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. 1320nm: The Cynosure Affirm Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles. 1440nm: The Cynosure Affirm Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles and pigmented lesions. The XPL Pulsed Light System Handpiece is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne. The Affirm Family System Laser Attachment is intended for: Er:YAG 2,940 nm - for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues.

Device Story

Nd:YAG laser system emitting 1064nm, 1320nm, and 1440nm wavelengths; incorporates XPL pulsed light handpiece and Er:YAG laser module (2940nm). Operated by foot switch; used in clinical dermatology and general surgery settings by trained professionals. Laser energy targets soft tissue for incision, excision, ablation, vaporization, or coagulation. XPL handpiece provides pulsed light for hair reduction and vascular/pigmented lesion treatment. Er:YAG module performs skin resurfacing. Device output allows clinicians to treat various skin conditions, vascular lesions, and wrinkles, potentially improving patient aesthetic and dermatological health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nd:YAG laser (1064nm, 1320nm, 1440nm); Er:YAG laser (2940nm); XPL pulsed light handpiece. Foot switch activation. Dimensions: 65" x 23" x 68". Power: 230 VAC, 15A, 50-60 Hz, single phase.

Indications for Use

Indicated for patients requiring dermatological or general surgical procedures including coagulation/hemostasis of vascular lesions, treatment of benign cutaneous/pigmented lesions, tattoo reduction, wrinkle/fine line treatment, skin resurfacing, permanent hair reduction, and inflammatory acne treatment.

Regulatory Classification

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 II Family laser
• Cynosure PhotoSilk Plus Pulsed Light System with Laser Attachment

Submission Summary (Full Text)

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K080006

## 510(K) Summary

| | 510(K) Summary | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter: | Cynosure, Inc. | |
| | 5 Carlisle Road | |
| | Westford, MA 01886 | |
| Contact: | George Cho | |
| | Senior Vice President of Medical Technology | |
| Date Summary Prepared: | December 31, 2007 | |
| Device Trade Name: | Cynosure Affirm Family Laser with XPL Handpiece and Er:YAG<br>Laser Module | |
| Common Name: | Medical Laser System | |
| Classification Name: | Instrument, surgical, powered, laser | |
| | 79-GEX | |
| | 21 CFR 878.4810 | |
| Equivalent Device: | Cynosure YAG MIR II Family laser, and Cynosure PhotoSilk Plus<br>Pulsed Light System with Laser Attachment | |
| Device Description: | The Affirm Family Laser with XPL Handpiece and Er:YAG Laser<br>Module is a Nd:YAG laser system. It emits wavelengths at 1064nm,<br>1320nm, and 1440nm. It also incorporates an XPL Handpiece an a<br>Er:YAG Module. | |
| | Laser emission activation is by foot switch. Overall weight of the laser<br>is 180 lbs., and the size is 65" x 23" x 68" (LxWxH). | |
| | Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase. | |
| Intended Use: | 1064nm: The Cynosure Affirm Family laser is intended for the coagulation and<br>hemostasis of benign vascular lesions, such as, but not limited to, port wine stains,<br>hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and<br>poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts,<br>scars, striae and psoriasis. The laser is also intended for the treatment of benign<br>pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun<br>spots), Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin<br>tags, keratoses, tattoos (significant reduction in the intensity of black and/or<br>blue/black tattoos) and plaques.<br>The laser is also indicated for the treatment of wrinkles such as, but not limited to,<br>periocular and perioral wrinkles. | |
| | 1320nm: The Cynosure Affirm Family laser is indicated for use in general surgery<br>and dermatology for the incision, excision, ablation, vaporization, coagulation and<br>hemostasis of soft tissue. It is also indicated for the treatment of periorbital and<br>perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles. | |
| | 1440nm: The Cynosure Affirm Family laser is indicated for use in general surgery<br>and dermatology for the incision, excision, ablation, vaporization, coagulation and<br>hemostasis of soft tissue. It is also indicated for the treatment of periorbital and<br>perioral wrinkles and pigmented lesions. | |
| | The XPL Pulsed Light System Handpierce is intended for permanent hair reduction<br>and the treatment of dermatological vascular lesions, facial and leg veins, benign<br>pigmented lesions, and inflammatory acne. | |
| | The Affirm Family System Laser Attachment is intended for: Er:YAG 2,940 nm - for<br>skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily<br>tissues. | |

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The Cynosure Affirm Family Laser with XPL Handpiece and Er: Y AG Comparison: Laser Module has the same indications for use, the same principle of operation, and the same wavelength as the predicate devices. Nonclinical Performance Data: none Clinical Performance Data: none The CynosureAffirm Family Laser is a safe and effective device for Conclusion: the indications specified. Additional Information: none

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is simple and monochromatic.

FEB 2 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cynosure % Mr. George Cho Sr. Vice President 5 Carlisle Road Westford, Massachusetts 01886

Re: K080006

Trade/Device Name: Cynosure Affirm Family Laser with Er:YAG Laser Module Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 19, 2008 Received: February 20, 2008

Dear Mr. Cho:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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); good manufacturing practice requirements as set

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Page 2 - Mr. George Cho

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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely vours.

Mark M Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1 of

510(k) Number (if known):

Cynosure Affirm Family Laser with Er: YAG Laser Module Device Name:

Indications For Use:

1064nm: The Cynosure Affirm Family laser is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), Café au lait macules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

1320mm: The Cynosure Affirm Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.

1440mm: The Cynosure Affirm Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles and pigmented lesions.

The XPL Pulsed Light System Handpiece is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.

The Affirm Family System Laser Attachment is intended for: Er: YAG 2,940 nm - for skin resurfacing and for the incision, ablation or vaporization of soft bodily tissues.

> OR Prescriptive Use X (Part 21 CFR 801 Subpart D)

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)

(Division Sign-Destorative,

510(k) Number K080006