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Found 9 results
510(k) Data Aggregation
K Number
K003993Device Name
DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)
Manufacturer
DORNIER SURGICAL PRODUCTS, INC.
Date Cleared
2001-03-26
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DORNIER SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000072Device Name
DORNIER MEDILAS D SKINPULSE
Manufacturer
DORNIER SURGICAL PRODUCTS, INC.
Date Cleared
2000-06-12
(154 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DORNIER SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001243Device Name
DORNIER MEDILAS H
Manufacturer
DORNIER SURGICAL PRODUCTS, INC.
Date Cleared
2000-05-24
(36 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DORNIER SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993146Device Name
DORNIER SCANNER HANDPIECE
Manufacturer
DORNIER SURGICAL PRODUCTS, INC.
Date Cleared
1999-11-08
(49 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DORNIER SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, ablation, and coagulation of soft tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing.
The Dornier Scanner is for use as an accessory for the Dornier Medilas E Laser (K981438). It is indicated for use in medicine and surgery in the medical specialties as listed in the Indication for Use Statement for the Dornier Medilas E Laser System.
No new indications are being requested.
Device Description
The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, ablation, and coagulation of soft tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing. The Dornier Scanner is for use as an accessory for the Dornier Medilas E Laser (K981438).
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K Number
K991183Device Name
DORNIER LASERTRODE FIBER
Manufacturer
DORNIER SURGICAL PRODUCTS, INC.
Date Cleared
1999-06-09
(62 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DORNIER SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Domier Lasertrode fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes, or for open surgery for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Dornier Lasetrode is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT and General Surgery.
Device Description
Not Found
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K Number
K984591Device Name
DORNIER MEDILAS H/2
Manufacturer
DORNIER SURGICAL PRODUCTS, INC.
Date Cleared
1999-03-26
(88 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DORNIER SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dornier Medilas H/2 Laser is intended to be used in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparascopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).
The Dornier Medilas H/2 Laser is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.
Device Description
Not Found
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K Number
K982629Device Name
DORNIER MEDILAS D
Manufacturer
DORNIER SURGICAL PRODUCTS, INC.
Date Cleared
1998-09-14
(48 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DORNIER SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dornier Medilas D Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).
The Dornier Medilas D is indicated for use in medicine and surgery, in the following medical specialties:
- Urology
- Plastic Surgery
- General Surgery
- Dermatology
- Gynecology
- Pulmonary Surgery
- Gastroenterology
- ENT
- Radiology
Device Description
The Dornier Medilas D laser is a 50 W diode laser that emits laser radiation in the invisible range of 940 nm. It offers laser power of 0-50 W at the distal tip of the light guide, adjustable in 1 W steps, and offers adjustable pulse duration. It has software controlled operating modes including Standard, Fibertom, LITT and LPS. It uses a 0.1mW Diode laser aiming beam with a wavelength of 645 nm. It incorporates a graphic display showing laser operating parameters, application modes, time functions, system status and messages for the user. It has a cooling system which includes an air-cooled, temperature controlled internal closed circuit water system. It is based on a single shutter with two parallel running microprocessors.
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K Number
K981438Device Name
DORNIER MEDILAS E
Manufacturer
DORNIER SURGICAL PRODUCTS, INC.
Date Cleared
1998-07-20
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DORNIER SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dornier Medilas E Laser is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Dornier Medilas E may also be used for skin resurfacing.
The Dornier Medilas E is indicated for use in medicine and surgery, in the following medical specialties:
- Dermatology
- Plastic Surgery
- General Surgery
- Urology
- Gynecology
- Pulmonary Surgery
- Gastroenterology
- ENT
- Thoracic Surgery
- Oral & Maxillofacial Surgery
- Ophthalmology
- Podiatry
Device Description
Not Found
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K Number
K981718Device Name
DORNIER MEDILAS H
Manufacturer
DORNIER SURGICAL PRODUCTS, INC.
Date Cleared
1998-07-17
(63 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DORNIER SURGICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dornier Medilas H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery. The Dornier Medilas H Laser is indicated for use in medicine and surgery, in the following specialities: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.
Device Description
The Dornier Medilas H Pulsed Holmium YAG Laser is a compact pulsed HO:Yag laser emitting laser radiation in the invisible range of 2080 nm. The Medilas H provides a temperature controlled method for contact cutting and non contact coagulation and vaporization with a bare fiber.
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