(88 days)
Not Found
No
The summary describes a pulsed diode laser system with various handpieces and a footswitch. There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description or performance studies.
Yes
Explanation: The device is intended for surgical, aesthetic, and cosmetic applications, including the treatment of benign vascular lesions, benign pigmented lesions, and hair reduction, all of which are therapeutic interventions.
No
The device is intended for surgical, aesthetic, and cosmetic applications, including treatment of vascular and pigmented lesions and hair reduction. There is no mention of it being used to diagnose conditions.
No
The device description explicitly states it comprises a main console unit, a handpiece, and a footswitch, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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 and Intended Use: The MeDioStar NeXT Family laser system is described as a pulsed diode laser used for surgical, aesthetic, and cosmetic applications directly on the patient's skin (treatment of vascular lesions, pigmented lesions, and hair reduction). It operates with a handpiece in contact with the skin.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens taken from the body. Its function is to deliver laser energy to the skin.
Therefore, based on the provided information, the MeDioStar NeXT Family laser system is a therapeutic/surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MeDioStar NeXT Family laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar NeXT Family laser system is intended for the treatment of benign vascular lesions.
The MeDioStar NeXT Family laser system is intended for the treatment of benign pigmented lessons.
The MeDioStar NeXT Family laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The MeDioStar NeXT and the MeDioStar NeXTPRO (The MeDioStar NeXT Family) are pulsed diode lasers emitting a wavelength of 755 - 950 nm, that are operated with a handpiece in contact with the skin. The lasers are a modification to previously cleared MeDioStar NeXT K111851. All systems comprise a main console unit, a handpiece and are triggered by means of a footswitch. There are several handpieces, the user can chose from.
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)
Nonclinical Performance Data: None
Clinical Performance Data: None
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.
MeDioStar NeXT K111851, Alma Lasers 755 nm Diode Module K140009
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines extending from their chins. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2015
Asclepion Laser Technologies GmbH Antje Katzer Regulatory Affairs Manager Brüsseler Straße 10 07747 Jena, Thuringia Germany
Re: K143519
Trade/Device Name: MeDioStar NeXT Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: February 5, 2015 Received: February 11, 2015
Dear Ms. Antje Katzer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143519
Device Name
MeDioStar NeXT Family
Indications for Use (Describe)
The MeDioStar NeXT Family laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar NeXT Family laser system is intended for the treatment of benign vascular lesions.
The MeDioStar NeXT Family laser system is intended for the treatment of benign pigmented lessons.
The MeDioStar NeXT Family laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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Image /page/3/Picture/0 description: The image shows the logo for Asclepion Laser Technologies. The word "Asclepion" is written in gray, and below it, "Laser Technologies" is written in a smaller font, also in gray. To the right of the word "Asclepion" is a cluster of blue circles of varying sizes, arranged in a pattern.
Asclepion Laser Technologies GmbH • Brüsseler Str. 10 • 07747 Jena • Germany
Special 510(k) SUMMARY
MeDioStar NeXT Family
This Special 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MeDioStar NeXT Family is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbH
Bruesseler Str. 10
07747 Jena, Germany |
|---------------------------|---------------------------------------------------------------------------------|
| Contact Person: | Mrs. Antje Katzer
Product Management and
International Regulatory Affairs |
| Phone:
Fax:
e-mail: | +49 3641 77 00 309
+49 3641 77 00 302
antje.katzer@asclepion.com |
| Preparation Date: | March 5, 2015 |
| Device Name: | MeDioStar NeXT Family |
| Common Name: | Diode Laser |
Our general terms and conditions: www.asclepion.com
Registered office: Jena Register of commerce court: Jena HRB 209648 UST ID Nr. DE 813678553 WEEE-Reg.-Nr. DE 33663120 Managing Director: Dr. Danilo Leggieri
Bank Connections: Sparkasse Jena • SWIFT HELADEF1JEN • IBAN DE 348305303000000000094 Deutsche Bank Jena • SWIFT DEUTDE8EXXX • IBAN DE 67820700000397755000 Commerzbank Jena • SWIFT COBADEFF821 • IBAN DE 54820400000258272400
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| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in
dermatology
79-GEX
21 CFR 878.4810
Regulatory Class: Class II
Product Code: GEX |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalent Devices: | MeDioStar NeXT K111851 |
| | Alma Lasers 755 nm Diode Module K140009 |
| Device Description: | The MeDioStar NeXT and the MeDioStar NeXTPRO (The MeDioStar NeXT
Family) are pulsed diode lasers emitting a wavelength of 755 - 950 nm, that
are operated with a handpiece in contact with the skin. The lasers are a
modification to previously cleared MeDioStar NeXT K111851. All systems
comprise a main console unit, a handpiece and are triggered by means of a
footswitch. There are several handpieces, the user can chose from. |
| Intended Use: | The MeDioStar NeXT Family laser system is intended for surgical, aesthetic
and cosmetic applications in the medical specialties of general and plastic
surgery and dermatology. |
| | The MeDioStar NeXT Family laser system is intended for the treatment of
benign vascular lesions. |
| | The MeDioStar NeXT Family laser system is intended for the treatment of
benign pigmented lesions. |
| | The MeDioStar NeXT Family laser system is intended for hair removal,
permanent hair reduction defined as reduced hair growth with or without
maintenance when measured at 6, 9 and 12 months. |
5
Summary of Technical Characteristics
| | Un-Modified Predicate
Device | Un-Modified Predicate
Device | Proposed Modified Device | Proposed Modified Device |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| | MedioStar NeXT | Alma Lasers 755 nm Diode
Module | The MeDioStar NeXT Family | |
| | | | MeDioStar NeXTPRO | MeDioStar NeXT |
| | K111851 | K140009 | | |
| Intended Use | Intended for surgical,
aesthetic and cosmetic
applications in the medical
specialties of general and
plastic surgery and
dermatology.
Intended for the treatment of
vascular lesions.
Intended for hair removal,
permanent hair reduction and
the treatment of pigmented
lesions. | Permanent reduction in hair
regrowth.
Treatment of benign vascular
and pigmented lesions.
Indicated for use on all skin
types
(Fitzpatrick skin types I - VI),
including tanned skin.
Permanent reduction in hair
regrowth is defined as long
term, stable reduction in the
numbers of hairs re-growing
when measured at 6, 9 and 12
months after the completion
of a treatment regime. | Intended for surgical, aesthetic and cosmetic applications
in the medical specialties of general and plastic surgery
and dermatology.
Intended for the treatment of benign vascular lesions.
Intended for the treatment of benign pigmented lesions.
Intended for hair removal, permanent hair reduction
defined as reduced hair growth with or without
maintenance when measured at 6, 9 and 12 months. | |
| Device Type | Diode Laser | Diode Laser | Diode Laser | Diode Laser |
| Wavelength | 800 - 950 nm | 755 nm | 755 - 950 nm | 755-950 nm |
| Pulse Duration | Up to 400 ms | Up to 200 ms | Up to 400 ms | Up to 400 ms |
| Repetition Rate | 4 - 12 Hz | 0,5 – 10 Hz | 4 - 12 Hz | 4 – 12 Hz |
| Spot Sizes
(Handpieces) | 13 x 10 mm² (ST)
4 x 3 mm² (VAS)
8 x 6 mm² (HP) | 150 mm² | 13 x 10 mm² (ST)
4 x 3 mm² (VAS)
8 x 6 mm² (HP)
13 x 10 mm² (ALX)
30 x 10 mm2 (XL+XLS)
38 x 24 mm2 (XL+XLL) | 13 x 10 mm² (ST)
4 x 3 mm² (VAS)
8 x 6 mm² (HP)
13 x 10 mm² (ALX) |
| Max. Fluence
(Handpieces) | 44 J/cm² (ST)
90 J/cm² (HP)
210 J/cm² (VAS) | 120 J/cm² | 44 J/cm² (ST)
90 J/cm² (HP)
210 J/cm² (VAS)
35 J/cm² (ALX)
60 J/cm² (XL+XLS)
20 J/cm² (XL+XLL) | 44 J/cm² (ST)
90 J/cm² (HP)
210 J/cm² (VAS)
35 J/cm² (ALX) |
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Comparison to: The MeDioStar NeXT Family laser system is substantially equivalent to the MeDioStar NeXT K111851 with the same principles of operation, with similar parameter and the same indications for use. The fundamental scientific technology of the device is unchanged from the legally marketed predicate. The MeDioStar NeXT Family laser with handpiece ALX (755 nm) system is substantially equivalent to the Alma Lasers 755 nm Diode Module K140009 with similar parameter and the same Indications for use. Nonclinical Performance Data: None Clinical Performance Data: None Conclusion: The MeDioStar NeXT Family laser system is another safe and effective device for the treatment of benign vascular lesions, for hair removal, permanent hair reduction and the treatment of benign pigmented lesions.