SELLAS

K080382 · Dinona Co., Ltd. · GEX · Sep 24, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080382
• Device Name: SELLAS
• Applicant: Dinona Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SellaS® is intended for use in : Dermatological procedures requiring the coagulation of soft tissue;

Device Story

SellaS® is a laser surgical instrument used in dermatology for soft tissue coagulation. Device operates by delivering laser energy to target tissue; intended for use by trained clinicians in a clinical setting. Output is controlled laser energy for surgical coagulation. Benefits include precise tissue management during dermatological procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Laser surgical instrument; Class II; Product Code GEX; 21 CFR 878.4810. Specific materials, energy parameters, and dimensions not detailed in provided text.

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation. No specific patient population, age, or gender restrictions provided.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle design, with the eagle's head and body formed by a series of curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Public Health Service

FEB 17 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dinona Company, Ltd. % Regulatory Insight, Inc. Mr. Kevin Walls Principal Consultant 13 Red Fox Lane Littleton, Colorado 80127

Re: K080382 Trade/Device Name: SellaS® 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: September 24, 2008 Received: September 24, 2008

Dear Mr. Walls:

This letter corrects our substantially equivalent letter of September 24, 2008.

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 (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 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. Kevin Walls

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 continue 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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely vours.

F.R. Peter o Rums

Mark N. Melkerson Director Division of General, Restorative 7/5 and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for use

F0282 510K Number (If known):

Device Name : SellaS®

The SellaS® is intended for use in :

Dermatological procedures requiring the coagulation of soft tissue;

Prescription Use __ x (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 C H, ice of Device Evaluation (ODE)

Db. Olin

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number.