UM-L20/ UM-L30

K982860 · Union Medical Engeneering Co., Ltd. · GEX · Aug 13, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K982860
• Device Name: UM-L20/ UM-L30
• Applicant: Union Medical Engeneering Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UM-L20/UML30 CO2 Laser Units are used in the following applications in order to treat the below mentioned conditions: ENT: Adenoidectomy, Oral Tumors, Rhinophyma, Tumors, Nasal Polyps, Hemostasis, Rhinitis, Keratosis, Tonsillectomy, Verruce, Nevi, Skin Tags. Plastic & Reconstruction: Xanthoma, Nasal Polyps, Condyloma, Rhinitis, Tumors, Telangiectasia, Hemostasis, Rhinophyma, Keloids, Keratosis, Skin Tags, Skin Incisions, Verruce, Nevi. Dermatology: Xanthoma, Telangiectasia, Rhinophyma, Condyloma, Tumors, Hemostasis, Keloids, Verruce, Skin Tags, Nevi, Dark Spots, Corn, Syringoma. Podiatry: Tumors, Hemostasis, Keloids, Verruce, Skin Tags, Nevi, Skin Incision. Dentalogy: Gingival Incision & Excision, Tissue Retraction for Impression, Frenectomy & Frenotomy, Aphthous Ukers, Excisional & Incisional Biopsies, Draining of Abscesses, Hemostatic Assistance, Implant Exposure, Soft Tissue Crown Lengthning, Operculectomy. General Practice: Rhinitis, Tumors, Keloids, Keratosis, Verrucae, Skin Tags, Nevi, Xanthoma, Condyloma. Gynecology: Condyloma, Conization, Tumors, Hemostasis, Keloids, Keratosis, Verrucae, Skin Tags, Nevi. Proctology: Tumors, Hemostasis, Hemorrhoids, Keloids, Keratosis, Verrucae, Skin Tags, Nevi, Skin Incisions. Federal Law restricts the use of this device by or on the order of a qualified physician only.

Device Story

UM-L20/UM-L30 are CO2 laser systems designed for surgical soft tissue management. Device generates laser energy to perform incision, excision, ablation, vaporization, and hemostasis. Operated by qualified physicians in clinical settings. Physician directs laser beam to target tissue; thermal energy causes precise tissue destruction or coagulation. Output is controlled laser radiation. Benefits include precise tissue removal and effective hemostasis during surgical procedures.

Clinical Evidence

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

Technological Characteristics

Carbon Dioxide (CO2) laser system. Energy source: CO2 gas laser. Form factor: Clinical unit with laser delivery accessories. Intended for surgical soft tissue applications including incision, excision, and hemostasis.

Indications for Use

Indicated for patients requiring surgical soft tissue procedures including incision, excision, ablation, vaporization, and hemostasis across ENT, plastic surgery, dermatology, podiatry, dentistry, gynecology, and proctology. Contraindications not specified.

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 circular logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around a central symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines above them that resemble a bird in flight or a stylized representation of movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 13 1999

Union Medical Engineering Co., Ltd. c/o Ms. Annie Velez Director She Medical Systems 1200 N.W. 78th Avenue Suite 110 Miami, Florida 33126

Re: K982860

> Trade Name: UM-L20; UM-L30 Carbon Dioxide Laser and Accessories

Regulatory Class: II Product Code: GEX Dated: May 3, 1999 Received: June 21, 1999

Dear Ms. Velez:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Annie Velez

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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## INDICATION FOR USE STATEMENT

510(k) Number: K982860

CO2 Lasers Device Name:

UM-L20/UM-L30 Device Model:

Indications for Use:

The UM-L20/UML30 CO2 Laser Units are used in the following applications in order to treat the below mentioned conditions:

: :

| ENT | Plastic & Reconstruction | Dermatology | Podiatry |
|---------------|--------------------------|----------------|---------------|
| Adenoidectomy | Xanthoma | Xanthoma | Tumors |
| Oral Tumors | Nasal Polyps | Telangiectasia | Hemostasis |
| Rhinophyma | Condyloma | Rhinophyma | Keloids |
| Tumors | Rhinitis | Condyloma | Verruce |
| Nasal Polyps | Tumors | Tumors | Skin Tags |
| Hemostasis | Telangiectasia | Hemostasis | Nevi |
| Rhinitis | Hemostasis | Keloids | Skin Incision |
| Keratosis | Rhinophyma | Verruce | |
| Tonsillectomy | Keloids | Skin Tags | |
| Verruce Nevi | Keratosis | Nevi | |
| Skin Tags | Skin Tags | Dark Spots | |
| | Skin Incisions | Corn | |
| | Verruce | Syringoma | |
| | Nevi | | |

Acote

(Division Sign-Off)
Division of General Restorative Devices K982860
510(k) Number

Prescription Use (Per 21 CFR 801.109)

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## Indication for Use, Page 2 K982860, UM-L20 & UM-L30 CO2 Lasers

Gingival Incision & Excision Tissue Retraction for Impression Frenectomy & Frenotomy Aphthous Ukers Excisional & Incisional Biopsies Draining of Abscesses Hemostatic Assistance Implant Exposure Soft Tissue Crown Lengthning Operculectomy

Dentalogy

General Practice

Rhinitis

Tumors

Keloids

Keratosis

Verrucae

Skin Tags

Nevi

Xanthoma

Condyloma

Gynecology

## Proctology

- Condyloma Conization Tumors Hemostasis Keloids Keratosis Verrucae Skin Tags Nevi
Tumors Hemostasis Hemorrhoids Keloids Keratosis Verrucae Skin Tags Nevi Skin Incisions

Federal Law restricts the use of this device by or on the order of a qualified physician only.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use K

OR Over the Counter Use

(Per 21 CFR 801.109)

padilla

Division Sign-Off) Division of General Restorative Devices/ 9822860 510(k) Number