PHACOILLUMINATOR - FIBEROPTIC SLEEVE
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)
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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.
