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510(k) Data Aggregation
K Number
K951033Device Name
ANDELA DYNAMIC COOLING DEVICE
Manufacturer
CANDELA LASER CORP.
Date Cleared
1996-08-15
(528 days)
Product Code
IMD
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
CANDELA LASER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Candela Dynamic Cooling Device is to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to reduce pain associated with laser treatment.
Device Description
Candela's Dynamic Cooling Device consists of 1) a source of skin refrigerant fluid (CFC R-12), 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with an SPTL laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of CFC R-12 just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Thermal injury to non-vascular structures is minimized and pain associated with the laser treatment is reduced.
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K Number
K955662Device Name
CANDELA Q-SWITCHED ALEXANDRITE LASERS
Manufacturer
CANDELA LASER CORP.
Date Cleared
1996-06-14
(185 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CANDELA LASER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
intended for use in the treatment of pigmented lesions and tattoos.
Device Description
The Candela Q-Switched Alexandrite Lasers utilize an alexandrite rod (crystal) which emits pulsed energy at 755 nm in the near-infrared region of the electromagnetic spectrum. An electro-optical Q-Switch is employed to control pulse duration. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Q-Switched Alexandrite Lasers are designed with five major components:
- the high voltage power supply and modulator system; 1)
- 2) the optical laser head;
- 3) the circulator system;
- 4) the microprocessor-based system controller and user display panel;
- 5) the optical delivery system.
The Candela Q-Switched Alexandrite Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an on-board control panel to regulate operation during treatment.
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K Number
K955011Device Name
CANDELA HCS 2000 URETHERAL WARMER CATHETER
Manufacturer
CANDELA LASER CORP.
Date Cleared
1996-04-03
(154 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CANDELA LASER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Candela HCS 2000 Urethral Warmer Catheter System is designed to transfer heat into the urethral membrane during cryosurgical ablation of prostatic tissue using the Cryotech LCS 3000 Cryosurgical System.
Device Description
The principal components of the Candela Urethral Warmer are: (1) a saline bottle filled with a saline solution; (2) infrared lamps; (3) a temperature controller; (4) a roller pump; (5) delivery tubing and a balloon catheter with a radiopaque marker at its center; (6) pump tubing (7) return tubing; (8) a urethral/bladder sound (K950633); and (9) a console. The console houses the saline reservoir, the infrared lamps, and the roller pump and digital temperature readouts and buttons for operating the device appear on the front of the console.
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K Number
K954872Device Name
CANDELA CRYO-PROBE HOLDER
Manufacturer
CANDELA LASER CORP.
Date Cleared
1996-02-05
(104 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CANDELA LASER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954934Device Name
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
Manufacturer
CANDELA LASER CORP.
Date Cleared
1996-02-02
(98 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CANDELA LASER CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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