novianhealth.comNovilase Laser Therapy System, Model LTS-2
NOVIAN HEALTH, INC.
NOVIAN HEALTH INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009383334 | 3009383334 | NOVIAN HEALTH INC. | 1 | N | 2026-01-01 | 222 Merchandise Mart Plz Ste 228 Chicago IL US 60654 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00196852073344 | Novilase Laser Therapy Pack - Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 150 mm laser probe with removable stylet and 1 temperature sensor, (1) 150 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in Switzerland. | 3122667200 | info@novianhealth.com |
| 00860008944801 | Novilase Laser Therapy Pack - Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 110 mm laser probe with removable stylet and 1 temperature sensor, (1) 110 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in USA/EU/UK. | 3122667200 | info@novianhealth.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 136319 | 1232142484 | K160392 | Novilase Laser Therapy System, Model LTS-2 | GEX | 2016-02-26 |
| 136319 | 1312131541 | K070353 | KELSEY INTERSITITAL LASER THERAPY SYSTEM | GEX | 2007-05-02 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEX | 2 | 2016-02-26 |
PMN#
GUDID#
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Novilase Laser Therapy Pack - Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 150 mm laser probe with removable stylet and 1 temperature sensor, (1) 150 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in Switzerland.
2023-12-13
Novilase Laser Therapy Pack - Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 150 mm laser probe with removable stylet and 1 temperature sensor, (1) 150 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in Switzerland.
2023-11-15
Novilase Laser Therapy Pack - Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 150 mm laser probe with removable stylet and 1 temperature sensor, (1) 150 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in USA/EU/UK
2023-11-15
Novilase Laser Therapy Pack - Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 110 mm laser probe with removable stylet and 1 temperature sensor, (1) 110 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in Switzerland.
2023-11-15
Novilase Laser Therapy Pack - Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 110 mm laser probe with removable stylet and 1 temperature sensor, (1) 110 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in USA/EU/UK.
2023-11-12