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
Capsulorrhexis Forceps, Inamura Style	AS7-111S	FDA UDI	Class I	Active
LRI/Toric Markers	AS3-504S	FDA UDI	Class I	Active
Capsule Polishers	AS9-073	FDA UDI	Class I	Active
Nucleus Manipulators/Choppers	AS9-056	FDA UDI	Class I	Active
Stevens Curved Tenotomy Hook, 6mm	AS8-063	FDA UDI	Class I	Active
LRI/Toric Markers	AS3-505	FDA UDI	Class I	Active
Capsulotomy Scissors	AS12-039	FDA UDI	Class I	Active
Lachrymal Cannulas	AS13-1105S	FDA UDI	Class I	Active
Eye Scissors	AS12-081	FDA UDI	Class I	Active
Ophthalmic Speculum	AS50-1100VS	FDA UDI	Class I	Active
Kremer Fixation Forceps, With Lock, Stainless Steel	AS7-400S	FDA UDI	Class I	Active
Black Diamond Crescent Tunnel Knives	AS6-081	FDA UDI	Class I	Active
Kelman-McPherson Tying Forceps, Angled 7mm, Stainless Steel	AS7-441S	FDA UDI	Class I	Active
Watzke Sleeve Spreading Forceps, Titanium	AS7-570T	FDA UDI	Class I	Active
Beveled Mendez Degree Gauge, Stainless Steel	AS2-010S	FDA UDI	Class I	Active
Kuglen Iris Hook, Straight, Titanium	AS8-023T	FDA UDI	Class I	Active
Ziegler Cilia Forceps, Titanium	AS7-250S	FDA UDI	Class I	Active
Mendez Degree Gauge, Titanium	AS2-006T	FDA UDI	Class I	Active
Helveston Tissue Retractor, "Great Big Barbie", 11mm wide	AS1-256	FDA UDI	Class I	Active
LASEK Instruments	AS3-711	FDA UDI	Class I	Active
Castroviejo Corneal Forceps, .3mm, 1x2Teeth, 6mm Tying Platform, Flat 85mm, Tita	AS7-346T	FDA UDI	Class I	Active
Step Knives for Cataract Surgery and LRI	AS6-200	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-110KT	FDA UDI	Class I	Active
Irrigation/Aspiration Cannulas	AS13-1400R	FDA UDI	Class I	Active
Trabeculotome	AS14-205L-T	FDA UDI	Class I	Active
Terry DSEK Scrapper, Stainless Steel	AS8-202S	FDA UDI	Class I	Active
Salz Type Nucleus Splitter	AS9-003	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-004S	FDA UDI	Class I	Active
Stitch Scissors	AS12-040	FDA UDI	Class I	Active
Kelman-McPherson Tying Forceps, Angled 4mm, Stainless Steel	AS7-440S	FDA UDI	Class I	Active
PRK, LASIK, LASEK, IntraLasik and Flap Management Instruments	AS3-613	FDA UDI	Class I	Active
Bonn Corneal Forceps, Straight, .12mm 1x2 Teeth, 85mm, Stainless Steel	AS50-7320S	FDA UDI	Class I	Active
Sapphire Trapezoid Knives	AS6-043	FDA UDI	Class I	Active
LRI/Toric Markers	AS3-501	FDA UDI	Class I	Active
Castroviejo Suturing Forceps, .5mm, 1x2 Teeth, No Tying Platform, Flat, Stainles	AS7-354S	FDA UDI	Class I	Active
Sapphire Crescent Tunnel Knives	AS6-020	FDA UDI	Class I	Active
Hydrodissection	AS13-1225-23g	FDA UDI	Class I	Active
Femtosecond Instruments	AS3-851S	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-002-11-HW	FDA UDI	Class I	Active
Phaco Choppers	AS9-035	FDA UDI	Class I	Active
Sapphire Universal & Side Port Knives	AS6-001	FDA UDI	Class I	Active
Keratoplasty Spatula	AS8-133	FDA UDI	Class I	Active
Sub-Tenon Cannulas	AS13-1021-19g	FDA UDI	Class I	Active
Nugent Utility Forceps, Serrated	AS50-7279S	FDA UDI	Class I	Active
Nagahara Phaco Chopper and Drysdale Nucleus Manipulator, Titanium	AS9-021RT	FDA UDI	Class I	Active
Phaco Choppers	AS9-030R	FDA UDI	Class I	Active
Irrigation/Aspiration Cannulas	AS13-1402	FDA UDI	Class I	Active
Hydrodissection	AS13-1226-23g	FDA UDI	Class I	Active
Pierce Corneal Forceps, .12mm, 1x1 Teeth, Very Delicate, Flat, 106mm, Stainless	AS7-322S	FDA UDI	Class I	Active
Ophthalmic Speculum	AS50-1001SR	FDA UDI	Class I	Active

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