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
Bores Optical Zone Marker, 7.0mm	AS3-150-7.0	FDA UDI	Class I	Active
Castroviejo Corneal Forceps, .5mm, 1x2 Teeth, 6mm Tying Platform, Flat, Stainles	AS7-352S	FDA UDI	Class I	Active
Sapphire Crescent Tunnel Knives	AS6-023	FDA UDI	Class I	Active
Castroviejo Corneal Forceps, .12mm, 1x2 Teeth, 6mm Tying Platform, Flat, Stainle	AS7-350S	FDA UDI	Class I	Active
Gimbel Stabilization Ring, Offset 13mm with 9mm opening, Blunt Teeth On Both Sid	AS1-352S	FDA UDI	Class I	Active
DSEK Markers	AS3-410-8.0	FDA UDI	Class I	Active
Capsulotomy Scissors	AS12-031	FDA UDI	Class I	Active
LASIK Cannulas	AS13-1701-27g	FDA UDI	Class I	Active
Kelman-McPherson Tying Forceps, Angled 12mm, Titanium	AS7-443T	FDA UDI	Class I	Active
Lachrymal Cannulas	AS13-1100C	FDA UDI	Class I	Active
Angled Phaco Knives	AS6-120	FDA UDI	Class I	Active
Universal Straight Knives	AS6-103	FDA UDI	Class I	Active
Braunstein Fixed Caliper (3.5mm-4.0mm), Stainless Steel	AS2-005S	FDA UDI	Class I	Active
Burrato LASIK Flap Forceps, Disk Shaped, Serrated Jaws, Titanium	AS7-703T	FDA UDI	Class I	Active
Bi-Manual Irrigation/Aspiration	AS10-023	FDA UDI	Class I	Active
Nagahara Chopper and Quick Chopper, Double Ended	AS9-022R	FDA UDI	Class I	Active
Capsulorrhexis Forceps	AS7-112T	FDA UDI	Class I	Active
Nucleus Manipulators/Choppers	AS9-054	FDA UDI	Class I	Active
Strabismus Scissors	AS12-060	FDA UDI	Class I	Active
McPherson Straight Tying Forceps, 5mm Tying Platform, 85mm, Stainless Steel	AS50-7430S	FDA UDI	Class I	Active
Capsulorrhexis Forceps	AS7-1051T	FDA UDI	Class I	Active
Jayles Forceps	AS7-280S	FDA UDI	Class I	Active
Corneal Transplant Markers	AS3-400	FDA UDI	Class I	Active
Corneal Markers	AS3-200T-10	FDA UDI	Class I	Active
Phaco Choppers	AS9-042	FDA UDI	Class I	Active
Black Diamond Crescent Tunnel Knives	AS6-082	FDA UDI	Class I	Active
Tenotomy Scissors	AS12-053	FDA UDI	Class I	Active
Needle Holders	AS11-018T	FDA UDI	Class I	Active
Manhatten E&E Suturing Forceps, .7mm, 1x2 Teeth, 6mm Tying Platform, Flat, Stain	AS7-380S	FDA UDI	Class I	Active
Needle Holders	AS11-024T	FDA UDI	Class I	Active
Fine/Thornton Fixation Ring With Swivel, 13mm Diameter, 11mm Opening, Titanium	AS1-350T	FDA UDI	Class I	Active
Punches	AS14-303	FDA UDI	Class I	Active
Troutman Superior Rectus Forceps, .5mm 1x2 Teeth, Titanium	AS7-547T	FDA UDI	Class I	Active
Fenzl Hook, Angled	AS8-020	FDA UDI	Class I	Active
Rust Ring Removal Instruments	AS4-100B	FDA UDI	Class I	Active
PRL & ICL Implantation	AS3-904	FDA UDI	Class I	Active
PRK, LASIK, LASEK, IntraLasik and Flap Management Instruments	AS3-612	FDA UDI	Class I	Active
Hoffer Optical Zone Marker	AS3-100T-5.75	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-052	FDA UDI	Class I	Active
Needle Holders	AS11-004T	FDA UDI	Class I	Active
Faulkner Lens Holding Forceps, Stainless Steel	AS7-600S	FDA UDI	Class I	Active
LASIK Cannulas	AS13-1700-V	FDA UDI	Class I	Active
Colibri-Castroviejo Corneal Forceps	AS7-308T	FDA UDI	Class I	Active
PRL & ICL Implantation	AS3-902	FDA UDI	Class I	Active
Steinert Paddle Lens Folding Forceps, Flat Handle, Titanium	AS7-602T	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-080	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-011	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-100BAS	FDA UDI	Class I	Active
Nagahara II Phaco Chopper, RHD, 2mm Blunt Tip, 1.25mm Cutting Edge	AS9-0201R	FDA UDI	Class I	Active
Bores Corneal Fixation Forceps, Stainless Steel	AS7-407S	FDA UDI	Class I	Active

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