Cleared Traditional

K832706 - SENSITIVE EYES

K832706 · Bausch & Lomb, Inc. · Ophthalmic device

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Oct 1983

Decision

53d

Days

Risk

K832706 is an FDA 510(k) clearance for the SENSITIVE EYES. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bausch & Lomb, Inc. devices

Submission Details

510(k) Number	K832706 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 12, 1983
Decision Date	October 04, 1983
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

57d faster than avg

Panel avg: 110d · This submission: 53d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	HPX Lens, Contact (polymethylmethacrylate)
Device Class	-

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 7

Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K832706.

BAUSCH & LOMB LENS CARRYING CASE

K854968 · Bausch & Lomb, Inc. · Apr 1986

SIGHT SAVER ALL PURPOSE LENS CARRYING CASE

K852384 · Bausch & Lomb, Inc. · Jul 1985

CLERZ LUBRICATING & REWETTING EYE DROPS

K830740 · CooperVision, Inc. · Jun 1983

BAUSCH & LOMB STERILE ALL PURPOSE SOLU

K820511 · Bausch & Lomb, Inc. · Apr 1982

CONCENTRATED CLEANER FOR HARD CONTACTS

K820818 · Bausch & Lomb, Inc. · Apr 1982

LENSINE EXTRA STRENGTH CLEANER

K812433 · CooperVision, Inc. · Sep 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K832706

Bausch & Lomb, Inc.

Mchenry, IL · US

Regulatory profile

92 submissions 92 cleared

100% clearance rate · Active in Ophthalmic

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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