ELITE + LASER SYSTEM

K141425 · Cynosure, Inc. · GEX · Sep 11, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141425
• Device Name: ELITE + LASER SYSTEM
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 11, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

755 nm: The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064 nm: The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, 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), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Device Story

Cynosure Elite+ Laser is a dual-wavelength (755 nm Alexandrite, 1064 nm Nd:YAG) medical laser system. Device inputs include user-selected parameters via control interface; laser activation via finger or foot switch. System transforms electrical energy into laser output for dermatological procedures. Modifications include four larger handpieces (18, 20, 22, 24 mm) and internal adjustments (rod diameter, lamp fill pressure) to Alexandrite laser to maintain fluence at larger spot sizes. Used in clinical settings by trained professionals. Software automatically detects attached handpiece to control energy delivery, preventing fluence increases for existing spot sizes. Output is laser energy applied to patient skin for coagulation, hemostasis, or hair reduction. Benefits include expanded treatment area capabilities while maintaining performance specifications of predicate device.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by non-clinical bench testing and software verification confirming the device meets product system requirements.

Technological Characteristics

Dual-wavelength laser system: 755 nm (Alexandrite crystal rod) and 1064 nm (Nd:YAG). Power: 208/240 VAC, 30A, 50/60 Hz. Dimensions: 41 x 15 x 25 in; Weight: 180 lbs. Spot sizes: 3, 5, 7, 10, 12, 15, 18, 20, 22, 24 mm. Pulse duration: 0.1-300 ms. Repetition rate: 1-5 Hz (755 nm), 1-10 Hz (1064 nm). Software-controlled energy delivery based on handpiece identification.

Indications for Use

Indicated for permanent hair reduction (all Fitzpatrick skin types I-VI, including tanned skin), treatment of vascular lesions (e.g., port wine stains, hemangiomas, telangiectasia, leg veins), benign pigmented lesions (e.g., lentigos, nevi, seborrheic keratoses), wrinkles, scars, striae, psoriasis, and pseudofolliculitis barbae.

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

• Apogee Elite (K034030)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 11, 2014

Cynosure Incorporated Ms. Kelli McMillan Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886

Re: K141425 Trade/Device Name: Cynosure Elite+ 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: August 11, 2014 Received: August 13, 2014

Dear Ms. McMillan:

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 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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Indications for Use

510(k) Number (if known) K141425

Device Name Cynosure Elite+ Laser

### Indications for Use (Describe)

755 nm:

The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowting when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

#### 1064 nm:

The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, 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), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Type of Use (*Select one or both, as applicable*)

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------|-----------------------------------------------------------|
|------------------------------------------------------------|-----------------------------------------------------------|

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# 510k Summary Elite+ Laser Special 510(k) K141425

| 807.92(a)(1) Submitter Information | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Cynosure, Inc |
| Address | 5 Carlisle Road |
| | Westford, MA 01886 |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Establishment Registration Number | 1222993 |
| Contact Person | Kelli McMillan |
| Preparation Date | September 10, 2014 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | Elite+ Laser |
| Common or Usual Name | Medical Laser System |
| Classification | II |
| Regulation Name | Laser Surgical Instrument for Use in General and Plastic Surgery<br>and in Dermatology |
| Classification Panel | General & Plastic Surgery |
| Regulation | 878.4810 |
| Product Code(s) | GEX |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| | Apogee Elite K034030 |
| 807.92(2)(4) Device Description | |
| | Cynosure Elite+ laser has an Alexandrite crystal rod as the lasing<br>medium, with a wavelength of 755 nm. The 1064 nm wavelength<br>is generated from the Nd:YAG laser head. |
| | Laser activation is by either by finger or foot switch. The overall<br>weight of the laser is 180 lbs and the size is 41 x 15 x 25 in<br>(HxWxD). |
| | Electrical equipment is 208/240 VAC, single phase, 30A, 50/60<br>Hz. |
| | The modifications to this device are four handpieces allowing<br>for a larger treatment area; 18 mm, 20 mm, 22 mm and 24 mm.<br>The 1064 Nd:YAG laser did not require any modifications to<br>support the new handpieces. Minor modifications, including<br>rod diameter change and lamp fill pressure change, were made<br>to the Alexandrite laser to increase the energy to support the<br>larger spot sizes. The software continues to control the energy<br>based on the handpiece attached. This prevents the increase in<br>available energy from the laser from increasing the fluence of<br>the existing spot sizes. |
| 807/92(a)(5) Intended Use of the Device | |
| | 755 nm:<br>The Cynosure Elite+ Laser is indicated for stable long-term, or<br>permanent hair reduction. Permanent hair reduction is defined<br>as long-term stable reduction in the number of hairs regrowing |
| K141425 | |
| when measured 6, 9, or 12 months after the completion of a<br>treatment regime. It is used for all skin types (Fitzpatrick I-VI)<br>including tanned skin. It is also indicated for the treatment of<br>vascular lesions, benign pigmented lesions, and wrinkles. | |
| 1064 nm: | |
| The Cynosure Elite+ Laser is intended for the coagulation and<br>hemostasis of benign vascular lesions such as, but not limited to,<br>port wine stains, hemangiomas, warts, telangectasia, rosacea,<br>venus lake, leg veins, spider veins and poikiloderma of civatte;<br>and treatment of benign cutaneous lesions such as warts, scars,<br>striae and psoriasis. The laser is also intended for the treatment<br>of benign pigmented lesions such as, but not limited to, lentigos<br>(age spots), solar lentigos (sun spots), cafe au lait macules,<br>seborrheic keratoses, nevi, chloasma, verrucae, skin tags,<br>keratosis and plaques. | |
| The laser is also indicated for the treatment of wrinkles such as,<br>but not limited to, periocular and perioral wrinkles. Additionally,<br>the laser is indicated for the treatment of pseudofolliculitis<br>barbae (PFB) and for stable long-term, or permanent hair<br>reduction. Permanent hair reduction is defined as long-term<br>stable reduction in the number of hairs regrowing when<br>measured at 6, 9 and 12 months after the completion of a<br>treatment regime. | |

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# 510k Summary Elite+ Laser Special 510(k)

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# 510k Summary Elite+ Laser Special 510(k) K141425

| 807.92(a)(6) Summary of the Technological Characteristics of the Device compared to the Predicate | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------|-------------------------------|------------|--|
| | Elite+<br>K141425 | | Apogee Elite<br>K034030 | | |
| Laser Type | Alexandrite and Nd:YAG Lasers | | Alexandrite and Nd:YAG Lasers | | |
| Wavelength | 755 nm | 1064 nm | 755 nm | 1064 nm | |
| Maximum Fluence | 60 J/cm | 300 J/cm | 60 J/cm | 300 J/cm | |
| Repetition Rate | 1 to 5 Hz | 1 to 10 Hz | 1 to 5 Hz | 1 to 10 Hz | |
| Pulse Duration | 0.1-300 ms | | 0.1-300 ms | | |
| Spot Sizes (mm) | 3, 5, 7, 10, 12, 15, 18, 20, 22, 24 | | 3, 5, 7, 10, 12.5, 15 | | |
| 807.92(b)(1) Non-clinical tests submitted | | | | | |
| Test | Result | | | | |
| Software | The testing confirmed that the software specifications were met. | | | | |
| 807.92(b)(2) Clinical tests submitted | | | | | |
| None | | | | | |
| 807.92(b)(3) Conclusions drawn from non-clinical data | | | | | |
| Testing confirmed that the performance of the Elite+ Laser meets the product system requirements, which is based on the predicate device. | | | | | |
| Therefore, the modification resulted in a device that performs within the same specifications of the predicate device, and is therefore | | | | | |

substantially equivalent.