SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS

K121127 · Cynosure, Inc. · GEX · May 13, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121127
• Device Name: SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440mm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers' cleared indications for use, such as the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands) and laser assisted lipolysis. SideLaze800™ may be used in combination with a Cynosure SMA-compatible laser system for the same indications.

Device Story

SideLaze800™ is a side-firing fiber optic delivery accessory for Cynosure 1440nm wavelength surgical lasers. It functions by directing laser energy laterally to the fiber axis, facilitating soft tissue procedures including incision, excision, vaporization, ablation, coagulation, and laser-assisted lipolysis. Used in clinical settings by physicians, the device attaches to existing laser systems to deliver optical energy to target tissues. The output allows for precise tissue interaction as determined by the host laser's parameters. It provides a specialized delivery method for existing cleared laser indications, potentially improving access or control during minimally invasive surgical or dermatological procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Side-firing fiber optic delivery accessory for 1440nm wavelength lasers. Materials are equivalent to previously cleared Cynosure delivery systems (K091537, K102541). Conforms to Laser Performance Standard 21 CFR 1040. Compatible with Cynosure SMA-compatible laser systems.

Indications for Use

Indicated for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (skin, cutaneous/subcutaneous tissue, muscle, cartilage, mucous membrane, lymph vessels/nodes, organs, glands) and laser-assisted lipolysis using Cynosure 1440nm wavelength lasers.

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 Multiwavelength Laser with 1440nm Wavelength (K091537)
• Cynosure Cellulaze Laser and Cellulaze Delivery Kit (K102541)
• Twister™ Side-Firing Optic Delivery System (K12987)

Submission Summary (Full Text)

{0}------------------------------------------------

K 121127

MAY 1 3 2012

# 510(k) Summary

.

| 510(K) Owner: | CYNOSURE, INC. |
|---------------|----------------------------------------------|
| | 5 Carlisle Road |
| | Westford, MA 01886 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Owner/Operator Number: 9006419 |
| Contact: | Irina Kulinets |
| | VP of Regulatory Affairs and Quality Systems |
| | CYNOSURE, INC. |
| | 5 Carlisle Road |
| | Westford, MA 01886 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Submitter: | Lori Kahler |
| | The RC Insight Group |
| | 461 Main Street, Suite 217 |
| | Pawtucket, RI 02860 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Manufacturer: | CYNOSURE, INC. |
| | 5 Carlisle Road |
| | Westford, MA 01886 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Establishment Registration Number: 1222993 |

12 April 2012 Date Prepared:

Addition of SideLaze800™ Option -Special 510(k)

8

Confidential

{1}------------------------------------------------

Trade name: SideLaze800™, laser beam delivery accessory for Cynosure 1440nm wavelength lasers

Powered Laser Surgical Instrument (Laser Common name: for Surgery and Dermatology)

Classification name: 21 CFR 878.4810

GEX (Laser Surgical Instrument for Use in General and Plastic Product Code(s): Surgery and in Dermatology)

Classification: Class II

Predicate Devices (Claiming Substantial Equivalence):

Cynosure Multiwavelength Laser with 1440nm Wavelength K091537

Cynosure Cellulaze Laser and Cellulaze Delivery Kit K102541

Twister™ Side-Firing Optic Delivery System K12987

Summary Description of the Device:

SideLaze800™ is an optional side-firing fiber optic accessory to the currently cleared Cynosure Lasers with 1440nm wavelength. The addition of the Cynosure SideLaze800™ option to the cleared laser devices is intended to offer physicians a convenient accessory within cleared indications for use.

{2}------------------------------------------------

### Intended Use / Indications for Use:

SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440mm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers' cleared indications for use, such as the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands) and laser assisted lipolysis. SideLaze800™ may be used in combination with a Cynosure SMA-compatible laser system for the same indications.

### Technological Characteristics:

The SideLaze800™ option contains equivalent components and patient-contact materials as the cleared delivery accessories of Cynosure Multiwavelength Laser with 1440nm wavelength (K091537) and Cynosure Cellulaze (K102541). The fundamental scientific technology of the modified device (addition of SideLaze800™ accessory) has not changed.

### Performance Standards:

This device conforms to the Laser Performance Standard (21 CFR 1040). No additional performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.

## Performance Data:

Performance (bench) testing summaries relating to the addition of the SideLaze800™ option is included in this submission.

#### Substantial Equivalence:

The SideLaze800™ option of the Cynosure 1440nm wavelength lasers is as safe and effective as the accessories cleared with the Cynosure Multiwavelength Lasers with 1440nm wavelength. The SideLaze800™ accessory option does not represent any fundamental changes in technology or any changes in indicated use, and this accessory option does not raise any additional questions of safety and effectiveness. In summary, the addition of the SideLaze800™ option used to deliver optical energy for Cynosure 1440nm wavelength lasers described in this submission is substantially equivalent to the predicate devices.

Confidential

{3}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Cynosure, Inc. % Ms. Irina Kulinets Vice President, Regulatory Affairs and Quality Systems 5 Carlisle Road Westford, Massachusetts 01886

MAY 1 3 2012

Re: K121127

Trade/Device Name: SideLaze800", Laser Beam Delivery Accessory for Cynosure 1440nm Wavelength Lasers

Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

plastic surgery and in dermatolo
. Class II

Regulatory Class: Class II Product Code: GEX Dated: May 08, 2012 Received: May 10, 2012

Dear Ms. Kulinets:

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.

{4}------------------------------------------------

### Page 2 - Ms. Irina Kulinets

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

For Robert chriſtopher Dri

Mark N. Melkerson · Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

K,121127

510(k) Number (if known):

Device Name:

SideLaze800™, laser beam delivery accessory for Cynosure 1440nm wavelength lasers

Indications for Use:

SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440nm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers' cleared indications for use, such as the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands) and laser assisted lipolysis. SideLaze800™ may be used in combination with a Cynosure SMA-compatible laser system for the same indications.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | Neil RP Ogden for mxn |
|--------------------------------------------------------|-----------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Surgical, Orthopedic, and Restorative Devices |

| Addition of SideLaze800™ Option - Special 510(k) | Confidential | Page 6 of 18 |
|--------------------------------------------------|--------------|--------------|
|--------------------------------------------------|--------------|--------------|

| 510(k) Number | K121127 |
|---------------|---------|
|---------------|---------|