(62 days)
The Dornier Medilas R Laser is intended to be used in a non-contact technical medical therapy unit, which is indicated for the dermatological application of epilation. The Medilas R is suitable for the following applications: General Surgery, Plastic Surgery, Cosmetology and Dermatology.
Not Found
The provided text is a 510(k) summary for the Dornier Medilas R Laser, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because it describes a different type of regulatory submission.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not found. This 510(k) summary does not define specific acceptance criteria or report device performance against such criteria. The submission is based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not found. No test set or clinical study data is presented in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not found. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not found. No test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not found. This device is a laser for dermatological applications, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not found. This device is a laser, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not found. No ground truth is mentioned as this is a substantial equivalence submission for a laser device.
8. The sample size for the training set
- Not applicable / Not found. No training set is mentioned.
9. How the ground truth for the training set was established
- Not applicable / Not found. No training set or ground truth establishment process is described.
Summary of what the document does provide:
- Predicate Devices:
- Intended Use / Indications for Use: The Dornier Medilas R Laser is intended to be used in a non-contact technical medical therapy unit, indicated for the dermatological application of general epilation, General Surgery, Plastic Surgery, Cosmetology, and Dermatology.
- Basis for Approval: Substantial equivalence to the predicate devices based on clinical perspective and design specifications. The submitter states "no significant differences exist" and "minor differences... should not raise any concerns regarding the overall safety or effectiveness."
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K984349
510(k) SUMMARY Dornier Surgical Products, Inc's Medilas R Laser
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Walter Payerl President 1155 Roberts Boulevard Kennesaw, GA 30144 (770) 426-1315 Phone: (770) 514-6288 Facsimile:
Carol Wernecke Contact Person: Director of Regulatory and Clinical Affairs 1155 Roberts Boulevard Kennesaw, GA 30144
Date Prepared: January 18, 1999
Name of Device and Name/Address of Sponsor
Medilas R Laser
Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144
Classification Name
FDA has not specifically classified Long Pulse Ruby lasers.
Predicate Devices
Dornier Medilas H Laser System Dornier Medilas E Laser System Mehl/Biophile Chromos 694 Sharplan EpiTouch Laser System
Intended Use
The Dornier Medilas R Laser is intended to be used in a non-contact technical medical therapy unit, which is indicated for the dermatological application of The Medilas R is suitable for the following applications: General epilation. Surgery, Plastic Surgery, Cosmetology and Dermatology.
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Technological Characteristics and Substantial Equivalence
From a clinical perspective and comparing design specifications, the Dornier Medilas R Laser and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices. Dornier Surgical Products. Inc. believes that no significant differences exist between the Dornier Medilas R and the predicate devices: the Dornier Medilas H (K981718), Medilas E (K981438),Mehl/Biophile Chromos 694 (K962109) and Sharplan EpiTouch (K972099).
Dornier Surgical Products, Inc believes the minor differences of the Dornier Medilas R and its predicate laser devices should not raise any concerns regarding the overall safety or effectiveness.
Advisory:
This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services-USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1999 FEB
Mr. Walter Payerl President Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, Georgia 30144
Re: K984349 Trade Name: Dornier Medilas R Laser Regulatory Class: II Product Code: GEX Dated: December 2, 1998 Received: December 4, 1998
Dear Mr. Payerl:
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 – Mr. Walter Payerl
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,
Stpt Rurbe
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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Dornier Surgical Products, Inc.'s Medilas R Laser
INDICATIONS FOR USE STATEMENT
| 510(K) Number: | K984349 |
|---|---|
| ---------------- | --------- |
Dornier Medilas R Laser ______________________________________________________________________________________________________________________________________________________ Device Name:
Indication For Use:
The Dornier Medilas R Laser is intended to be used in a non-contact technical medical therapy unit, which is indicated for the dermatological application of epilation. The Medilas R is suitable for the following applications: General Surgery, Plastic Surgery, Cosmetology and Dermatology.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-the-Counter Use | |
|---|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K984349 |
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.