(88 days)
Not Found
No
The summary describes a laser system for tissue ablation and does not mention any AI/ML components or functions. The performance studies section explicitly states that no performance data was required due to similarity to predicate devices, which is not typical for devices incorporating novel AI/ML algorithms.
Yes
The device is intended for medical procedures like coagulation, vaporization, ablation, or cutting of soft tissue, which are therapeutic interventions.
No
Explanation: The device is intended for coagulation, vaporization, ablation, or cutting of soft tissue, not for diagnosis.
No
The device description explicitly states it consists of a laser enclosure and fiber optic delivery system, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The DermaStar Er: YAG Laser System is a laser system used for surgical procedures on soft tissue (skin). It directly interacts with the patient's body for treatment purposes (coagulation, vaporization, ablation, cutting).
- Lack of In Vitro Testing: The description clearly states its intended use is for procedures on the body, not for testing samples taken from the body. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the DermaStar Er: YAG Laser System is a surgical laser device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DermaStar Er: YAG Laser System 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).
Product codes
GEX
Device Description
The DermaStar Er: YAG Laser System is an Erbium:YAG laser with a wavelength of 2.94um. It consists a laser enclosure and fiber optic delivery system (including hand piece).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin), skin around the eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professionals
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
None. The specifications and intended uses of the DermaStarEr:YAG laser system are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required.
Key Metrics
Not Found
Predicate Device(s)
Dermablate Er: YAG Laser System (K980361), MCL 29 Dermablate Er: YAG Laser System (K964128)
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
8 2002
MAR
510(k) SUMMARY ASCLEPION-MEDITEC AG DermaStar Er:YAG Laser System
This 510(k) summary of safety and effectiveness for the ASCLEPION-MEDITEC AG DermaStar Er: YAG Laser System is submitted in accordance with the requirements of SDMA 1990 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | ASCLEPION-MEDITEC AG |
|---|---|
| Address: | Goeschwitzer Strasse 51-52 |
| 07745 Jena, Germany | |
| Contact Person: | Dr. Dirk Colditz |
| Vice President Operations and | |
| International Regulatory Affairs | |
| Phone: | |
| Fax: | |
| e-mail: | +49 3641 220 501 |
| +49 3641 220 502 | |
| ctz@asclepion.com | |
| Preparation date: | September 2001 |
| Device name: | DermaStar Er: YAG Laser System |
| Common Name: | DermaStar |
| Classification | |
| Name: | Laser surgical instrument for use in general and plastic surgery |
| and in dermatology (21 CFR 878.4810) | |
| Product code: GEX - Laser instrument, surgical, powered | |
| Panel: 79 | |
| Legally marketed: | Dermablate Er: YAG Laser System (K980361) |
| MCL 29 Dermablate Er: YAG Laser System (K964128) | |
| Description: | The DermaStar Er: YAG Laser System is an Erbium:YAG laser |
| with a wavelength of 2.94um. It consists a laser enclosure and | |
| fiber optic delivery system (including hand piece). | |
| Intended Use: | The DermaStar Er: YAG Laser System 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). |
1
Premarket Notification DermaStar
Image /page/1/Picture/2 description: The image shows a handwritten alphanumeric string. The string is "KO14057". The characters are written in a bold, slightly slanted font. The image is a close-up of the string, with a white background.
Comparison to: The specifications of the DermaStar are the same as or very similar to those of legally marketed lasers such as Dermablate Er: YAG Laser System (K980361) and MCL 29 Dermablate Er: YAG Laser System (K964128) Performance data: None. The specifications and intended uses of the DermaStarEr:YAG laser system are the same or very similar to
- those of claimed predicate devices. Because of this, performance data were not required.
- The DermaStar Er: YAG laser system is substantially equivalent CONCLUSION: to legally marketed devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three human figures are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2002
Asclepion-Meditec AG c/o Mr. William Kelley Asclepion-Meditec, Inc. 23832 Via Monte Coto De Caza, CA 92708
Re: K014057
Trade/Device Name: DermaStar Er:YAG Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: November 27, 2001 Received: December 10, 2001
Dear Mr. Kelley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. William Kelley
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematicated predicated. The aclassification 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the prometion 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Onlor general mionnazion turers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
iriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 44 of 68
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K O14057
Device Name: _DermaStar Er: YAG Laser System
Indication For Use:
The DermaStar 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 laser system DermaStar is restricted to sale to or use by licensed professionals in the United States.
isiam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K014057
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Over-The-Counter Use