Who is the manufacturer of PHACOILLUMINATOR - FIBEROPTIC SLEEVE?

Michael Reynard, M.D. submitted the Traditional clearance for PHACOILLUMINATOR - FIBEROPTIC SLEEVE (K964018).

What is the FDA product code for PHACOILLUMINATOR - FIBEROPTIC SLEEVE?

HQC. It is classified under 21 CFR 886.4670 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for PHACOILLUMINATOR - FIBEROPTIC SLEEVE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PHACOILLUMINATOR - FIBEROPTIC SLEEVE?

silicone infusion sleeve (unspecified).

PHACOILLUMINATOR - FIBEROPTIC SLEEVE

K964018 · Michael Reynard, M.D. · HQC · Feb 26, 1997 · Ophthalmic

Device Facts

Record ID	K964018
Device Name	PHACOILLUMINATOR - FIBEROPTIC SLEEVE
Applicant	Michael Reynard, M.D.
Product Code	HQC · Ophthalmic
Decision Date	Feb 26, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4670
Device Class	Class 2

Intended Use

Provide illumination at surgical site.

Device Story

Clear silicone sleeve; fits over phacofragmentation handpiece; transmits light from internal fiber optic channels to surgical site. Used in ophthalmic surgery by surgeons. Enhances visualization of surgical field during phacoemulsification; facilitates surgical precision.

Clinical Evidence

Bench testing only.

Technological Characteristics

Clear silicone material; sleeve form factor; passive light transmission via fiber optic coupling; non-powered; sterile.

Indications for Use

Indicated for use during ophthalmic surgery to provide illumination at the surgical site.

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Predicate Devices

silicone infusion sleeve (unspecified)

Related Devices

K971750 — WELCH ALLYN PHACO ILLUMINATOR · Welch Allyn, Inc. · Jun 30, 1997
K960811 — PHACOSCOPE · Saint John'S Plaza Medical Group · Oct 2, 1996
K041108 — ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA · Iscience Surgical Corporation · Jun 22, 2004
K971338 — SYNTEC, INC. DISPOSABLE BARE END FIBER · Syntec, Inc. · May 6, 1997
K980027 — PEREGRINE SHIELDED DIFFUSION PROBE · Peregrine Surgical , Ltd. · Mar 31, 1998

Submission Summary (Full Text)

{0} K964018 # CONFIDENTIAL AND PROPRIETARY INFORMATION Page Three 510(k) Summary per section 807.92(c) Submitter Name: Michael Reynard, M.D. Address: 1301 - 20th Street #260, Santa Monica, CA 90404 Telephone: 310-453-0551 FAX: 310-315-0133 Contact Person: Michael Reynard, M.D. Date of Summary: 9/30/1996 Name of Device: Accessory Illuminating Infusion Sleeve Tradename of Device: Phacoilluminator™ Equivalence: The subject device is a predicate silicone infusion sleeve without opaque or tint additives. Description of Device: Clear silicone sleeve that transmits light originating from fiber optic channels contained in the phacofragmentation handpiece. Intended Use of Device: Provide illumination at surgical site. Comparison with predicate devices: Construction material is identical with currently manufactured silicone infusion sleeve except that opaque additives are omitted to allow for light transmission.