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FDA 510(k)

LPULSA SYL-9000 OPHTHALMIC YAG LASER

K-Number: K990075 · 1999-03-30

ApplicantLight-Med(Usa), Inc.
Decision Date1999-03-30
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LPULSA SYL-9000 OPHTHALMIC YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Light-Med(Usa), Inc.. It received FDA 510(k) clearance on 1999-03-30 under 510(k) number K990075. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LPULSA SYL-9000 OPHTHALMIC YAG LASER?

LPULSA SYL-9000 OPHTHALMIC YAG LASER is a medical device that received FDA 510(k) clearance on 1999-03-30. The listed applicant is Light-Med(Usa), Inc.. The 510(k) number is K990075.

When did LPULSA SYL-9000 OPHTHALMIC YAG LASER receive FDA 510(k) clearance?

LPULSA SYL-9000 OPHTHALMIC YAG LASER received FDA 510(k) clearance on 1999-03-30, under 510(k) number K990075.

Who is the listed applicant for LPULSA SYL-9000 OPHTHALMIC YAG LASER?

The FDA 510(k) record lists Light-Med(Usa), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LPULSA SYL-9000 OPHTHALMIC YAG LASER?

The FDA product code for LPULSA SYL-9000 OPHTHALMIC YAG LASER is HQF.

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Other records listing Light-Med(Usa), Inc. as applicant

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Official Source

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

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