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Found 6 results
510(k) Data Aggregation
K Number
K994116Device 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
878.4810Why 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.
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K Number
K992707Device 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
878.4810Why 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.
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K Number
K991285Device 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
878.4810Why 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.
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K Number
K981196Device Name
MEDITEC LINK
Manufacturer
AESCULAP-MEDITEC NORTH AMERICA
Date Cleared
1998-06-17
(90 days)
Product Code
HQF, HJO
Regulation Number
886.4390Why 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.
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K Number
K980361Device Name
DERMABLATE ER: YAG LASER SYSTEM
Manufacturer
AESCULAP-MEDITEC NORTH AMERICA
Date Cleared
1998-04-21
(82 days)
Product Code
GEX
Regulation Number
878.4810Why 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.
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K Number
K974467Device 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
886.1850Why 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.
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