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FDA 510(k)

LASER INDIRECT OPHTHALMOSCOPE (LIO)

K-Number: K885196 · 1989-01-11

ApplicantCoherent Medical Group
Decision Date1989-01-11
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LASER INDIRECT OPHTHALMOSCOPE (LIO) is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Medical Group. It received FDA 510(k) clearance on 1989-01-11 under 510(k) number K885196. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER INDIRECT OPHTHALMOSCOPE (LIO)?

LASER INDIRECT OPHTHALMOSCOPE (LIO) is a medical device that received FDA 510(k) clearance on 1989-01-11. The listed applicant is Coherent Medical Group. The 510(k) number is K885196.

When did LASER INDIRECT OPHTHALMOSCOPE (LIO) receive FDA 510(k) clearance?

LASER INDIRECT OPHTHALMOSCOPE (LIO) received FDA 510(k) clearance on 1989-01-11, under 510(k) number K885196.

Who is the listed applicant for LASER INDIRECT OPHTHALMOSCOPE (LIO)?

The FDA 510(k) record lists Coherent Medical Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASER INDIRECT OPHTHALMOSCOPE (LIO)?

The FDA product code for LASER INDIRECT OPHTHALMOSCOPE (LIO) is HQE.

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Other records listing Coherent Medical Group as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963339COHERENT ULTRAPULSE CO2 SURGICAL LASERSK960032COHERENT VERSAPULSE AESTHETIC SURGICAL LASERSK932981COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERSK923575COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERSK932468NOVUS MULTIWAVELENGTHK930981ACCULITE(TM) OTOPROBE

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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