Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K994116
    Device Name
    LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
    Manufacturer
    AESCULAP-MEDITEC NORTH AMERICA
    Date Cleared
    2000-06-01

    (178 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESCULAP-MEDITEC NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    The laser system MeDioStar H operates as a pulsed diode laser which emits a beam of coherent light at 808 nanometers.
    Ask a Question
    K Number
    K992707
    Device Name
    MCL 29 DERMABLATE ER:YAG LASER SYSTEM
    Manufacturer
    AESCULAP-MEDITEC NORTH AMERICA
    Date Cleared
    1999-10-19

    (69 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESCULAP-MEDITEC NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The laser system DERMABLATE ER:YAG LASER SYSTEM is intended for laser assisted site preparation for hair transplantation. This indication is in addition to previously cleared indications. The laser system DERMABLATE ER:YAG LASER SYSTEM is restricted to sale to or use by licensed professionals in the United States.
    Device Description
    The laser system DERMABLATE ER:YAG LASER SYSTEM is an Erbium:YAG laser with a wavelength of 2.94µm.
    Ask a Question
    K Number
    K991285
    Device Name
    LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE
    Manufacturer
    AESCULAP-MEDITEC NORTH AMERICA
    Date Cleared
    1999-07-12

    (88 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESCULAP-MEDITEC NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The laser system Ruby Star (operating in normal use) is intended to remove unwanted body hair. The laser system Ruby Star (operating in Q-Switch mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions. Some examples of pigment lesions are: Lentigines, Cafe-au-lait-blotches, Ephalides, Benign Naevi such as Nevus of Ota, Naevus of Ito, Epidermal naevi, Congenital naevi, Becker's naevi, Blue naevus, Naevus spilus, and Mongolian spot. The laser system Ruby Star is restricted to sale or use by licensed professionals in the United States
    Device Description
    The laser system RubyStar operates as a normal pulse or as a Q-Switched ruby laser which emits a beam of coherent light at 694 nanometers. In Q-Switched mode the beam has much shorter pulse duration than in the normal pulse mode.
    Ask a Question
    K Number
    K981196
    Device Name
    MEDITEC LINK
    Manufacturer
    AESCULAP-MEDITEC NORTH AMERICA
    Date Cleared
    1998-06-17

    (90 days)

    Product Code
    HQF, HJO
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESCULAP-MEDITEC NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Meditec Link is intended to be attached to slit lamps to allow green laser energy light to be delivered to the slit lamp via fiber optic. Once the Meditec Link is attached to a slit lamp the user should refer to the User's Manual or Operator's Manual provided with the laser for clinical use information regarding the laser and for additional use instructions or information. The Meditec Link is presently designed for attachment to Zeiss Slit Lamps or to Haag Streit 900 BQ and 900 BM Slit Lamps.
    Device Description
    The Meditec Link is an adapter which attaches to slit lamps, e.g., Zeiss Slit Lamps and Haag Streit 900 BQ and 900 BM Slit Lamps, to allow green laser light, to be delivered to the slit lamps. The laser light (532 nm) can then be directed to selected sites within the eye by an ophthalmologist.
    Ask a Question
    K Number
    K980361
    Device Name
    DERMABLATE ER: YAG LASER SYSTEM
    Manufacturer
    AESCULAP-MEDITEC NORTH AMERICA
    Date Cleared
    1998-04-21

    (82 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESCULAP-MEDITEC NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dermablate laser 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).
    Device Description
    The Dermablate laser is an erbium: YAG laser operating at 2.94 microns and with a maximum pulse energy of 2 J.
    Ask a Question
    K Number
    K974467
    Device Name
    AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
    Manufacturer
    AESCULAP-MEDITEC NORTH AMERICA
    Date Cleared
    1998-02-19

    (85 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    AESCULAP-MEDITEC NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SL07 and SL08 laser slit lamps are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. Both include an adapter to deliver green laser light (532 nm) to the slit lamp by fiber optic. The user should refer to the User Manual provided with the laser for clinical use information for the laser or for additional information.
    Device Description
    The SL07 and SL08 slit lamps are commercially available slit lamps which have been modified by Aesculap-Meditec to accommodate an adapter through which green laser light, e.g., from the EyeLite™ Laser, is delivered to the slit lamps. The laser light (532 nm) can then be directed to selected sites within the eye by an ophthalmologist.
    Ask a Question

    Page 1 of 1