SUILE OINTMENT WOUND DRESSING

K041013 · Hedonist Biochemical Technologies Co., Ltd. · FRO · Jul 7, 2004 · SU

Device Facts

• Record ID: K041013
• Device Name: SUILE OINTMENT WOUND DRESSING
• Applicant: Hedonist Biochemical Technologies Co., Ltd.
• Product Code: FRO · SU
• Decision Date: Jul 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The SUILE Ointment Wound Dressing is indicated for the management of 1ª and 2ª4 degree burns, partial thickness wounds, donor sites and abrasions.

Device Story

SUILE Ointment Wound Dressing is a topical wound care product applied to manage 1st and 2nd degree burns, partial thickness wounds, donor sites, and abrasions. It functions as a physical barrier/dressing to support wound healing. Used in clinical or home settings under prescription, it is applied by healthcare providers or patients to the wound site to protect the area and facilitate management of the specified wound types.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Topical ointment wound dressing. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for management of 1st and 2nd degree burns, partial thickness wounds, donor sites, and abrasions in patients requiring wound care.

Submission Summary (Full Text)

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Public Health Service

JUL - 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hedonist Biochemical Technologies Co., Ltd c/o Eric Luo, Ph.D. 2828 W. Parker Road, Suite #207 Plano, Texas 75075

Re: K041013

Trade/Device Name: SUILE Ointment Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 18, 2004 Received: April 20, 2004

Dear Dr. Luo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becement of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered print to May 20, 1978, the econdance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Free, market the device, subject to the general controls provisions of the Act. The r ou may, dierely mains of the Act include requirements for annual registration, listing of general controls provincities, 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 If your device is elassince (controls. Existing major regulations affecting your device can may or sabject to dash ware and 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 or unry 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 Orth 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.

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Page 2 - Eric Luo, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you're begin finding of substantial equivalence of your device to a legally promative hotifications on "ceresults 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 If you demo specific an 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 other general 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 yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K041013

Device Name: SUILE Ointment Wound Dressing

Indications For Use:

The SUILE Ointment Wound Dressing is indicated for the management of 1ª and 2ª4 degree burns, partial thickness wounds, donor sites and abrasions.

Prescription Use_ V (Per 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)

Miriam C. Provost

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

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510(k) Number K641013