(82 days)
The Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
The Dermablate laser is an erbium: YAG laser operating at 2.94 microns and with a maximum pulse energy of 2 J.
The provided text describes a 510(k) summary for the DERMABLATE ERBIUM LASER SYSTEM. It explicitly states that no performance data, acceptance criteria, or studies were required for this device.
Here's why, based on the provided text:
- The summary in section {1} states: "None. The specifications and intended uses of the Dermablate laser are the Performance Data: same or very similar to those of the claimed predicate devices, including the MCL 29 Dermablate. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."
Therefore, I cannot populate the requested information regarding acceptance criteria and studies. The device's clearance was based on its substantial equivalence to legally marketed predicate devices without the need for new performance testing.
{0}------------------------------------------------
APR 21 1998
510(k) SUMMARY
DERMABLATE ERBIUM LASER SYSTEM
This 510(k) summary of safety and effectiveness for the Dermablate erbium laser system is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | AESCULAP-MEDITEC |
|---|---|
| Address: | 23832 Via MonteCoto De Caza, CA 92679-4001 |
| Contact Person: | Mr. William T. KelleyAESCULAP-MEDITEC23832 Via MonteCoto De Caza, CA 92679-4001 |
| Telephone: | 714-589-8536714-589-6259 (Fax) |
| Preparation Date:(of the Summary) | January 1998 |
| Device Trade Name: | Dermablate Er:YAG Laser System |
| Common Name: | Erbium: Yttrium, Aluminum; Garnet (Er:YAG) Laser System |
| Classification Name: | Laser surgical instrument for use in general and plastic surgeryand in dermatology (see: 21 CFR 878.4810). Product Code:GEX. |
| Legally marketedpredicate(s): | MCL 29 Dermablate Continuum Biomed, Inc., MultiliteErbium Laser System |
| Description ofthe device: | The Dermablate laser is an erbium: YAG laser operating at 2.94microns and with a maximum pulse energy of 2 J. |
| Intended Use | The Dermablate laser is intended for coagulation, vaporization,ablation, or cutting of soft tissue (skin) in dermatology, plasticsurgery (including aesthetic surgery), oral surgery, andophthalmology (skin around the eyes) |
{1}------------------------------------------------
This intended use is the same or similar to that for the claimed predicate devices.
-
None. The specifications and intended uses of the Dermablate laser are the Performance Data: same or very similar to those of the claimed predicate devices, including the MCL 29 Dermablate. There are no significant differences between the devices under conditions of intended use.
Because of this, performance data were not required. -
CONCLUSION: Based on the foregoing and other information in this application, AESCULAP-MEDITEC believes that the Dermablate laser is substantially equivalent to legally marketed predicate devices, i.e., the MCL 29 Dermablate and the Continuum Biomed, Inc. Multilite erbium laser system (K961748 and K970934).
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, creating a sense of community and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 21 1996
Mr. William T. Kelly ·Aesculap-Meditec North America 23832 Via Monte Coto De Caza, California 92679
Re: K980361 Dermablate Er:YAG Laser System Trade Name: Requlatory Class: II Product Code: GEX Dated: January 27, 1998 Received: January 29, 1998
Dear Mr. Kelly:
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 reqistration, 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 requlation may result in requlatory 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.
{3}------------------------------------------------
Page 2 - Mr. Kelly
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.
Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
{4}------------------------------------------------
APPENDIX B
510(K) Number (if known):___K980361
Device Name: Dermablate Erbium Laser System
Indications For Use:
The Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 810109)
Over-The-Counter-Use
(Division Sign-Off) Divinn of Gene 5 Oky Numbe
:
064
§ 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.