(62 days)
Dornier Medilas H Laser System, Dornier Medilas E Laser System, Mehl/Biophile Chromos 694, Sharplan EpiTouch Laser System
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other indicators of AI/ML technology. The description focuses on the laser's intended use and predicate devices.
Yes
Explanation: The "Intended Use / Indications for Use" section states the device is a "non-contact technical medical therapy unit" indicated for dermatological application of epilation, which is a therapeutic treatment.
No
Explanation: The device is described as a "technical medical therapy unit" intended for dermatological epilation and other surgical/cosmetological applications, which are therapeutic rather than diagnostic.
No
The device description clearly identifies it as a "Laser" system, which is a hardware-based medical device. The 510(k) summary does not mention any software-only components or functions that constitute the primary medical device.
Based on the provided information, the Dornier Medilas R Laser is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "non-contact technical medical therapy unit" for "dermatological application of epilation" and other surgical/cosmetic applications. This describes a device used on the patient's body for treatment, not a device used to test samples from the body (which is the definition of an IVD).
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The device is a therapeutic laser used for procedures performed directly on the patient.
N/A
Intended Use / Indications 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.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dornier Medilas H Laser System, Dornier Medilas E Laser System, Mehl/Biophile Chromos 694, Sharplan EpiTouch Laser System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
2
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 ________________________________________________________________________________________________________________________________________________________________