(178 days)
Not Found
No
The summary describes a laser system for hair and vascular lesion removal. There is no mention of AI, ML, image processing, or any data-driven algorithms in the intended use, device description, or performance study summary.
Yes.
Explanation: The device is intended to remove unwanted body hair and vascular lesions, which are therapeutic interventions.
No
The device is described as a laser system for cosmetic procedures (hair removal and vascular lesions), not for diagnosing medical conditions. Its intended use focuses on treatment rather than diagnosis, and there is no mention of diagnostic functionalities, image processing, or AI/ML for diagnostic purposes.
No
The device description explicitly states it is a "laser system" and describes its physical operation (pulsed diode laser emitting a beam of coherent light), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove unwanted body hair and vascular lesions." This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laser system that emits light. It does not analyze biological samples.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or processes associated with IVDs (like reagents, assays, or analysis of bodily fluids).
This device is a therapeutic laser system used for direct treatment on the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The laser system MeDioStar H is intended to remove unwanted body hair and vascular lesions.
Product codes
GEX
Device Description
The laser system MeDioStar H operates as a pulsed diode laser which emits a beam of coherent light at 808 nanometers.
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
The laser system MeDioStar H is restricted to sale to or use by licensed professionals in the United States.
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)
None. The specifications and intended uses of the laser system MeDioStar H are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN - 1 2000
K994116
510(k) SUMMARY AESCULAP-MEDITEC GMBH LASER SYSTEM MeDioStar H WITH AND WITHOUT COOLING SYSTEM FOR SKIN
This 510(k) summary of safety and effectiveness for the AESCULAP-MEDITEC GMBH Laser System MeDioStar H with and without skin cooling 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: AESCULAP-MEDITEC GMBH
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Address: Prussingstrasse 41 07739 Jena, Germany
Contact Person: Dr. Dirk Colditz Quality Management Representative -
+49 3641 65 3453 Phone: Fax: +49 3641 65 3815 e-mail: ctz@aesculap.meditec.com
Preparation date: March 1999
Device name: Laser System MeDioStar H (with and without skin cooling system)
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Common Name: MeDioStar H ( without skin cooling system ) MeDioStar HC ( with skin cooling system )
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
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Coherent / Palomar LightSheer ( K982940 ) Legally marketed: LASERSCOPE - Lyra ( K990903 ) Candela - CANDELA GENTLELASE II DERMATOLOGICAL LASER ( K984601 )
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Description: The laser system MeDioStar H operates as a pulsed diode laser which emits a beam of coherent light at 808 nanometers.
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Intended Use: The laser system MeDioStar H is intended to remove unwanted body hair and vascular lesions.
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Comparison to: The specifications of the MeDioStar are the same as or
1
very similar to those of legally marketed lasers such as the Conerent / Palomar - LightSheer ( K982940 ), the LASERSCOPE - Lyra ( K990903 ) and the Candela - CANDELA GENTLELASE II DERMATOLOGICAL LASER ( K984601 )
- Performance data: None. The specifications and intended uses of the laser system MeDioStar H are the same or very similar to those of claimed predicate devices. Because of this , performance data were not required.
- The MeDioStar H is substantially equivalent to legally marketed CONCLUSION: devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2000
Mr. William Kelley Aesculap-Meditec North American 2525 McGaw Avenue Irvine, California 92623
K994116 Re:
R 77+110
Trade Name: Laser System MeDioStar H With and Without Skin Cooling System Laser System MeDioStar With and Without Skin Cooling System
Regulatory Class: II Product Code: GEX Dated: February 21, 2000 Received: March 7, 2000
Dear Mr. Kelley:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your boomer be device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to ase suted in the enactment date of the Medical Device Amendments, or to devices that May 20, 1970, the cities accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Fel (110). "The general controls provisions of the Act include requirements for provisions of and From 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 ( remailed in provide), with device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the I urrent 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 and assumptions. Failure to comply with the GMP regulation may result in regulatory Such assumptions: "Farma vos vour of Federal Register. Please note: this response to your premarket notification submission does r cochar regions. Tour 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. William Kelley
This letter will allow you to begin marketing your device as described in your 10(k) This letter will anow you to begin maineting , but antial equivalence of your device to a premarket nothleation. The PDA miding of substance of the results 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 If you desire specific advice 10- 75-diagnostic devices), please contact the Office of and additionally 607.10 for in 1150 and the promotions on the promotion and Compliance at (301) 594-4575. Atuationally, 1993 of Compliance at (301) 594-4639. advertising of your device, produs titled, "Misbranding by reference to premarket Also, prease flote the regulation entition, "Information on your responsibilities under the nothication (21 CPX 607.97). Other general 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,
Dana R. Kirchner
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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _Laser System MeDioStar H with and without skin cooling system
Indication For USE Statement:
The laser system MeDioStar H (with and without skin cooling system) is intended to remove unwanted body hair and vascular lesions.
The laser system MeDioStar H is restricted to sale to or use by licensed professionals in the United States.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
Dena R. bochner.
Division Sign-Off) Division of General Restorative Devices 510(k) Number