RODENSTOCK SLITLAMP (MODEL 5000 & 4000)

K962532 · Expertech Assoc., Inc. · HJO · Jul 25, 1996 · Ophthalmic

Device Facts

• Record ID: K962532
• Device Name: RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
• Applicant: Expertech Assoc., Inc.
• Product Code: HJO · Ophthalmic
• Decision Date: Jul 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The device and accessories are indicated as a noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses.

Device Story

Rodenstock RO 5000 and RO 4000 slitlamps; instruments for eye examination and contact lens fitting. Device integrates microscope with adjustable light source to create slit illumination of eye. Accessories enable measurement of eye characteristics and documentation of ocular shapes. Used in clinical settings by eye care professionals. Provides magnified visualization of ocular structures to assist in diagnosis and contact lens fitting.

Clinical Evidence

No clinical data; bench testing only. Substantial equivalence based on technological characteristics and intended use identical to predicate devices.

Technological Characteristics

AC-powered slitlamp biomicroscope; 6.3 to 12v AC, 50-60 Hz power source. Consists of microscope and adjustable slit light source. Supports standard ophthalmic accessories for tonometry, vitreous/fundus examination, and contact lens fitting.

Indications for Use

Indicated for use as a noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses for patients requiring ophthalmic evaluation.

Regulatory Classification

Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Haag-Streit slitlamp 900® BQ
• Topcon slitlamp model SL-2ED

Submission Summary (Full Text)

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JUL 25 1996
K962532

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. The submitter of this premarket notification is:

David M. Link, Vice President
EXPERTech™ Associates, Inc.
100 Main Street, Suite 120
Concord, MA 01742-5307
Telephone: [phone]
Fax: [phone]

This Summary was prepared on May 31, 1996.

2. The name of the device is the Rodenstock RO 5000 and RO 4000 Slitlamp. Its common name is the slitlamp and the classification name is the AC-powered slitlamp biomicroscope.

3. The RO 5000 device is substantially equivalent to the Haag-Streit brand slitlamp 900® BQ and the RO 4000 device is substantially equivalent to the Topcon brand slitlamp model SL-2ED.

4. The Rodenstock brand RO 5000 and RO 4000 slitlamps are instruments used for eye examination and the fitting of contact lenses. Each device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 6.3 to 12v AC and 50-60 Hz.

5. The device and accessories are indicated as a noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices.

6. The technological characteristics are the same or similar to those found with the predicate devices where the eye is examined by projecting light onto it. Additionally, standard accessories are used for tonometry, examining the vitreous and fundus of the eye and contact lens fitting as those claimed for the predicate devices.

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