INNOVAQUARTZ LLC

Address:23030 N 15TH AVE,Phoenix,AZ,85027,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

Clear

ProFlex™ - 00816959020101 Catalog Number : SLLF150SPY

Device Description : Maximum Power (J x PPS): 10WWavelengths Range: 500nm to 2200nm

Device Class : 2

Duns Number: 079295103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ProFlex™ - 00816959020118 Catalog Number : S-LLF200SPY

Device Description : Maximum Power (J x PPS): 30WWavelengths Range: 500nm to 2200nm

Device Class : 2

Duns Number: 079295103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ProFlex™ - 00816959020125 Catalog Number : S-LLF273SPY

Device Description : Maximum Power (J x PPS): 50WWavelengths Range: 500nm to 2200nm

Device Class : 2

Duns Number: 079295103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ProFlex™ - 00816959020132 Catalog Number : S-LLF365SPY

Device Description : Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm

Device Class : 2

Duns Number: 079295103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ProFlex™ - 00816959020149 Catalog Number : S-LLF273SPY-T

Device Description : Maximum Power (J x PPS): 50W. Compatible with Trimedyne Omnipulse Lasers: Not a Maximum Power (J x PPS): 50W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.

Device Class : 2

Duns Number: 079295103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ProFlex™ - 00816959020156 Catalog Number :

Device Class : 2

Duns Number: 079295103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ProFlex™ - 00816959020163 Catalog Number :

Device Class : 2

Duns Number: 079295103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ProFlex™ - 00816959020170 Catalog Number : S-LLF365SPY-T

Device Description : Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.

Device Class : 2

Duns Number: 079295103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ProFlex™ - 00816959020187 Catalog Number :

Device Class : 2

Duns Number: 079295103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ProFlex™ - 00816959020194 Catalog Number :

Device Class : 2

Duns Number: 079295103

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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