Question 1

What types of medical devices does Aurora Surgical, LLC manufacture?

Accepted Answer

Aurora Surgical, LLC specializes in reusable ophthalmic surgical instruments. These include probes for manipulating soft tissue, forceps for precise tissue handling, irrigation/infusion/aspiration cannulas, angular gauges, reusable knives, eyelid speculums, corneal scissors, and suture/needle passers. These tools are designed for procedures like cataract surgery, LASEK (Laser-Assisted Sub-Epithelial Keratomileusis), and trabeculectomy, ensuring precision and reliability in eye surgeries.

Question 2

Where is Aurora Surgical, LLC based?

Accepted Answer

Aurora Surgical, LLC is based in the United States. The company’s headquarters and operations are located within the country, aligning with its focus on manufacturing reusable ophthalmic surgical instruments for global use.

Question 3

Which regulatory registries list Aurora Surgical, LLC’s devices?

Accepted Answer

Aurora Surgical, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I ophthalmic surgical instruments, including reusable tools like probes, forceps, and cannulas, by assigning them a standardized identifier for tracking and compliance.

Question 4

How are Aurora Surgical, LLC’s ophthalmic devices classified by regulatory authorities?

Accepted Answer

Aurora Surgical, LLC’s reusable ophthalmic devices are classified as FDA Class I under regulatory frameworks. This classification applies to low-risk surgical instruments like reusable probes, forceps, and speculums, which are deemed to pose minimal risk to patients when used as intended. Class I devices typically undergo general controls rather than stringent pre-market approvals.

Device	Model / Reference	Registries	Class	Status
Lachrymal Cannulas	AS13-1104S-25g	FDA UDI	Class I	Active
Slade Femtosecond Spatula, Angled/Semi Vaulted 10mm Bend to Tip	AS8-300S	FDA UDI	Class I	Active
Needle Holders	AS50-11017S	FDA UDI	Class I	Active
Jeweler Forcep #4 Straight, 115mm, Titanium	AS7-523T	FDA UDI	Class I	Active
Flieringa Scleral Fixation Ring, 20mm Diameter	AS1-300-20	FDA UDI	Class I	Active
PRL Implantation Forceps, Angled, Titanium	AS7-662T	FDA UDI	Class I	Active
Knapp Lachrymal Sac Retractor, 4 Blunt Prongs	AS1-235	FDA UDI	Class I	Active
Side Port & MICS Knives	AS6-152	FDA UDI	Class I	Active
Trocar Holding Forceps	AS7-680	FDA UDI	Class I	Active
ICL Cartridge Loading Forceps, Stainless Steel	AS7-660S	FDA UDI	Class I	Active
Flieringa Scleral Fixation Ring, 12mm Diameter	AS1-300-12	FDA UDI	Class I	Active
Angled Phaco Knives	AS6-124	FDA UDI	Class I	Active
Sapphire Universal & Side Port Knives	AS6-015	FDA UDI	Class I	Active
Rust Ring Removal Instruments	AS4-101B	FDA UDI	Class I	Active
Utrata MICS Capsulorrhexis Forceps	AS7-112S	FDA UDI	Class I	Active
Castroviejo Double Ended Spatula And Spoon	AS8-131	FDA UDI	Class I	Active
Muscle Hooks	AS8-052	FDA UDI	Class I	Active
Lester Lens Manipulator, Straight	AS50-8025S	FDA UDI	Class I	Active
Lachrymal Cannulas	AS13-1100S	FDA UDI	Class I	Active
Corneal Trephines	AS4-300-9.5	FDA UDI	Class I	Active
Helveston Scleral Ruler	AS2-101	FDA UDI	Class I	Active
Nucleus Manipulators/Choppers	AS9-059	FDA UDI	Class I	Active
Sapphire Clear Cornea Phaco Spear Knives	AS6-035	FDA UDI	Class I	Active
Hoffer Optical Zone Marker	AS3-100S-7.5	FDA UDI	Class I	Active
Cilia Forceps, Narrow, Stainless Steel	AS7-252S	FDA UDI	Class I	Active
Beveled Mendez Degree Gauge, Titanium	AS2-010T	FDA UDI	Class I	Active
Perone LASIK Flap Forceps, 2mm Diameter Rings, 108mm	AS7-701S	FDA UDI	Class I	Active
Sapphire Universal & Side Port Knives	AS6-009	FDA UDI	Class I	Active
Graefe Fixation Forceps With Lock, Stainless Steel	AS7-401S	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-100VAS	FDA UDI	Class I	Active
Anesthesia / Cytotomes	AS13-1002-27g	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-016	FDA UDI	Class I	Active
Needle Holders	AS11-006T	FDA UDI	Class I	Active
Intralasik Instruments	AS3-802S	FDA UDI	Class I	Active
Double Ended Orbital Globe Retractor-Elevator, 10mm / 14mm	AS1-252	FDA UDI	Class I	Active
Tenotomy Scissors	AS50-12055S	FDA UDI	Class I	Active
Jameson Muscle Hook	AS50-8050S	FDA UDI	Class I	Active
Gass Retinal Detachment Hook	AS8-061	FDA UDI	Class I	Active
Adson Fixation Forceps With Teeth, Stainless Steel	AS7-503S	FDA UDI	Class I	Active
Tenotomy Scissors	AS12-051	FDA UDI	Class I	Active
Lester Lens Manipulator, Angled, Titanium	AS8-024T	FDA UDI	Class I	Active
Capsulotomy Scissors	AS50-12031S	FDA UDI	Class I	Active
Phaco Choppers	AS9-027R	FDA UDI	Class I	Active
Kelman-McPherson Tying Forceps, Angled 10mm, Stainless Steel	AS7-442S	FDA UDI	Class I	Active
Irrigation/Aspiration Cannulas	AS13-1401R	FDA UDI	Class I	Active
Helveston Tissue Retractor, "Barbie", 7mm wide	AS1-254	FDA UDI	Class I	Active
Hydrodissection	AS13-1226-25g	FDA UDI	Class I	Active
Dressing Forceps With Serrations, Curved, Titanium	AS7-501T	FDA UDI	Class I	Active
PRK, LASIK, LASEK, IntraLasik and Flap Management Instruments	AS3-622	FDA UDI	Class I	Active
Phaco Choppers	AS9-048	FDA UDI	Class I	Active

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