(365 days)
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, Dentalogy, General Practice, Gynecology, Proctology. Specific conditions are listed in tables.
Not Found
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a CO2 laser device (UM-L20 and UM-L30). It establishes the substantial equivalence of the device to a legally marketed predicate device and lists its indications for use.
However, the document does not contain any information regarding:
- Acceptance criteria and reported device performance: There are no specific performance metrics, benchmarks, or data presented.
- Details of any study: The document doesn't describe any studies conducted to prove the device meets acceptance criteria. This includes no information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with detailed performance reports as might be seen for devices needing PMA approval. Therefore, the information you are requesting is not typically included in these types of regulatory documents.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
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)
{3}------------------------------------------------
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.