POLARIS Q-SWITCH RUBY SYSTEM

K121162 · Sandstone Medical Technologies, LLC · GEX · Jul 18, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121162
• Device Name: POLARIS Q-SWITCH RUBY SYSTEM
• Applicant: Sandstone Medical Technologies, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polaris Long Pulse and Q-Switch Ruby Laser is intended to remove blue/black tattoos and benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery

Device Story

Polaris Long Pulse and Q-Switched Ruby Laser is a console-based surgical laser system. It delivers 694.3nm wavelength laser energy via an articulated arm and interchangeable handpieces to target melanin in hair follicles or pigment in tattoos/lesions. The device features a self-contained refrigerated de-ionized water cooling system. Operated by a physician in a clinical setting, the user activates the laser via a footswitch. The device provides two modes: Q-switched (25 ns pulse) for tattoo/lesion removal and Long Pulse (2 ms pulse) for hair removal. By selectively targeting melanin, the laser energy destroys hair follicles or breaks down pigment, facilitating hair removal or lesion clearance. The device is identical in design and performance to the predicate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pulsed Ruby laser (single lamp); 694.3nm wavelength; 633nm HeNe aiming beam. Q-switched mode: 25ns pulse, 1.25J max energy. Long pulse mode: 2ms pulse, 5J max energy. Articulated arm beam delivery. Self-contained refrigerated de-ionized water cooling. Power: 110V/220V 50/60 Hz. Dimensions: 840mm x 495mm x 680mm; Weight: 125kg.

Indications for Use

Indicated for removal of blue/black tattoos and benign dermal/epidermal pigmented lesions, and hair removal in patients with skin types 1-4 via selective melanin targeting in hair follicles. For use in dermatology and plastic surgery.

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

• LaseAway Long Pulse and Q-Switched Ruby Laser (K971193)

Submission Summary (Full Text)

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K 12.1162

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#### Attachment 5 510(K) Summary Polaris Long Pulse and Q-Switched Ruby Laser

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## This 510(K) Summary of safety and effectiveness for Polaris Long Pulse and Q-Switched Ruby Laseris submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) sümmary.

| Applicant: | Sandstone Medical Technologies, LLC | JUL 18 2012 |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Address: | 105 Citation Court<br>Birmingham, AL 35209 | |
| Contact Person: | Mark Rohrer | |
| Telephone: | 205-290-8251 - phone | |
| Email: | [e-mail] | |
| Preparation Date: | March 30, 2012 | |
| Device Trade Name: | Polaris Long Pulse and Q-Switched Ruby Laser | |
| Common Name: | Long Pulse and Q-Switch Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX, 21 CFR 878-48 | |
| Legally Marketed<br>Predicate Device: | LaseAway Long Pulse and Q-Switched Ruby Laser (K)971193 | |
| Description of the Polaris<br>Long Pulse and Q-<br>Switched Ruby Laser | The Polaris Long Pulse and Q-Switched Ruby Laser<br>and controls are contained in a single console. Electrical power<br>is supplied to the console by the facility's power source. Energy<br>is delivered using an articulated arm with interchangeable<br>handpieces to adjust spot size. The wavelength is 694.3nm.<br>The user activates laser by means of a footswitch. | |
| Intended use: | The Polaris Long Pulse and Q-Switch Ruby Laser is intended<br>to remove blue/black tattoos and benign dermal and epidermal<br>pigmented lesions, and, to effect hair removal of patients with<br>skin types 1-4 through selective targeting of melanin in hair<br>follicles in dermatology and plastic surgery | |
| Performance Data: | None | |
| Results of Clinical Study: | None | |
| Conclusion: | The Polaris Long Pulse and Q-Switched Ruby Laser<br>is identical to the predicate device in terms of indications for<br>use, technical specifications, operating performance features,<br>general design. | |

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### Attachment 5 510(K) Summary Polaris Long Pulse and Q-Switched Ruby Laser

# Technical Specifications Comparison

| | Polaris Long Pulse and Q-Switched Ruby Laser | LaseAway Q-Switch Ruby<br>(Predicate Device) |
|--------------------------------|----------------------------------------------|----------------------------------------------|
| Laser | Pulsed Ruby (Single lamp) | Pulsed Ruby (Single lamp) |
| Size | H840 mm x W495 mm x D680<br>mm | H840 mm x W495 mm x D680<br>mm |
| Weight | 125Kg | 125Kg |
| Power requirement | 110V/220V 50/60 Hz (16A peak) | 110V/220V 50/60 Hz (16A peak) |
| Cooling | Self contained refrigerated<br>chiller | Self contained refrigerated<br>chiller |
| Cooling medium | De-ionised water | De-ionised water |
| Wavelength | 694.3nm | 694.3nm |
| Aiming beam, HeNe | 633nm | 633nm |
| Repetition rate | 1Hz | 1Hz |
| Pulse duration, Q-<br>Switched | 25 ns | 25 ns |
| Pulse duration, Long<br>Pulse | 2ms | 2ms |
| Maximum energy Q-<br>Switched | 1.25 joules | 1.25 joules |
| Maximum energy, Long<br>Pulse | 5 joules | 5 joules |
| Spot size, Q-Switched | Selectable from 4, 5 and 6mm | Selectable from 4, 5 and 6mm |
| Spot Size, Long Pulse | Selectable from 5. 6 and 7mm | Selectable from 5. 6 and 7mm |
| Beam delivery | Articulated arm and focusing<br>handpiece | Articulated arm and focusing<br>handpiece |
| Ambient conditions | 15° to 26°C, 10 to 80% humidity | 15° to 26°C, 10 to 80% humidity |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Sandstone Medical Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Homewood, Alabama 35209

JUL 18 2012

Re: K121162

Trade/Device Name: Polaris Long Pulse and Q-Switched Ruby 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: June 30, 2012 Received: July 06, 2012

Dear Mr. Rohrer:

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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### Page 2 - Mr. Mark Rohrer

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 yours,

Eunice Keith

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

Enclosure

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# Indications for Use

K121162 510(k) Number (if known): ____

Device Name: Polaris Long Pulse and Q-Switched Ruby Laser

The Polaris Long Pulse and Q-Switched Ruby Laser is intended to remove blue/black tattoos and benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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. Order for mxm
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121162