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
Moorsfield Forceps, Stainless Steel	AS7-277S	FDA UDI	Class I	Active
Fixation Ring with 10 Degree Marks, Nichamin Style	AS1-356	FDA UDI	Class I	Active
Needle Holders	AS11-041S	FDA UDI	Class I	Active
Phaco Choppers	AS9-052R	FDA UDI	Class I	Active
Utrata Capsulorrhexis Forceps, Flat Handle	AS50-7100S	FDA UDI	Class I	Active
LASEK Instruments	AS13-1720	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-054	FDA UDI	Class I	Active
Air Injection / Anterior Chamber Cannulas	AS13-1205-23g	FDA UDI	Class I	Active
LRI/Toric Markers	AS3-509	FDA UDI	Class I	Active
Colibri-Bonn Corneal Forceps	AS7-309T	FDA UDI	Class I	Active
Tennant Curved Tying Forceps, Extra Delicate Tips, Round Handle, Titanium	AS7-456T	FDA UDI	Class I	Active
Putterman Lid Clamp, Titanium	AS7-550T	FDA UDI	Class I	Active
Bores Optical Zone Marker, 5.5mm	AS3-150-5.5	FDA UDI	Class I	Active
Corneal Markers	AS3-200S-4	FDA UDI	Class I	Active
Hoffer Optical Zone Marker, With Cross Hairs, 7mm, Stainless	AS3-100S-7.0	FDA UDI	Class I	Active
LASEK Instruments	AS3-705	FDA UDI	Class I	Active
Step Knives for Cataract Surgery and LRI	AS6-202	FDA UDI	Class I	Active
Probes	AS14-009T	FDA UDI	Class I	Active
Arruga Globe Retractor	AS1-251	FDA UDI	Class I	Active
DLEK Corneal Scissors	AS12-011	FDA UDI	Class I	Active
Rust Ring Removal Instruments	AS4-101	FDA UDI	Class I	Active
PRK, LASIK, LASEK, IntraLasik and Flap Management Instruments	AS3-627	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-141VS	FDA UDI	Class I	Active
PRL & ICL Implantation	AS3-931	FDA UDI	Class I	Active
PRK, LASIK, LASEK, IntraLasik and Flap Management Instruments	AS3-611	FDA UDI	Class I	Active
Charlie II DSEK Donor Forceps	AS7-801S	FDA UDI	Class I	Active
Step Knives for Cataract Surgery and LRI	AS6-203-SL	FDA UDI	Class I	Active
Double Fixation Hook, Sharp, Large	AS1-381	FDA UDI	Class I	Active
Capsule Polishers	AS13-1500-25g	FDA UDI	Class I	Active
Fukasaku Small Pupil Snapper Hook And Chopper	AS9-023	FDA UDI	Class I	Unknown
Berke Ptosis Forceps, Small, Titanium	AS7-544T	FDA UDI	Class I	Active
Nagahara II Phaco Chopper, RHD, 2mm Blunt Tip, 1.25mm Cutting Edge	AS9-0201L	FDA UDI	Class I	Active
Stitch Scissors	AS12-044	FDA UDI	Class I	Active
Ophthalmic Speculum	AS1-120S	FDA UDI	Class I	Active
Corneal Scissors	AS12-001R	FDA UDI	Class I	Active
Irrigation/Aspiration Cannulas	AS13-1401L	FDA UDI	Class I	Active
Capsule Polishers	AS13-1505	FDA UDI	Class I	Active
Utrata Capsulorrhexis Forceps, With Cystotome Tips	AS7-103S	FDA UDI	Class I	Active
Hydrodissection	AS13-1312	FDA UDI	Class I	Active
Lachrymal Cannulas	AS13-1110	FDA UDI	Class I	Active
Blade Breakers And Holders	AS4-005T	FDA UDI	Class I	Active
Probes	AS14-002	FDA UDI	Class I	Active
12' Bi-Polar Cable	AS7-480	FDA UDI	Class I	Active
Muscle Hooks	AS8-068	FDA UDI	Class I	Active
McPherson Curved Tying Forceps, 5mm Tying Platforms, Long Handle, 115mm, Stainle	AS7-434S	FDA UDI	Class I	Active
Cannulas	AS13-1900T	FDA UDI	Class I	Active
Bi-Manual Irrigation/Aspiration	AS10-030	FDA UDI	Class I	Active
Harms-Colibri Corneal Forceps	AS7-304T	FDA UDI	Class I	Active
Troutman Superior Rectus Forceps, .5mm 1x2 Teeth, Stainless Steel	AS7-547S	FDA UDI	Class I	Active
Paufique Suturing Forceps, .5 mm Teeth, 6mm Tying Platform, Titanium	AS7-360T	FDA UDI	Class I	Active

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