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FDA 510(k)

NANOLAS ND:YAG OPHTHALMIC LASER

K-Number: K881459 · 1988-04-13

ApplicantBiophysic Medical, Inc.
Decision Date1988-04-13
Product CodeLOI
DecisionSubstantially Equivalent

Device Summary

NANOLAS ND:YAG OPHTHALMIC LASER is the device name listed in this FDA 510(k) record. The listed applicant is Biophysic Medical, Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K881459. The device is classified under product code LOI. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NANOLAS ND:YAG OPHTHALMIC LASER?

NANOLAS ND:YAG OPHTHALMIC LASER is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Biophysic Medical, Inc.. The 510(k) number is K881459.

When did NANOLAS ND:YAG OPHTHALMIC LASER receive FDA 510(k) clearance?

NANOLAS ND:YAG OPHTHALMIC LASER received FDA 510(k) clearance on 1988-04-13, under 510(k) number K881459.

Who is the listed applicant for NANOLAS ND:YAG OPHTHALMIC LASER?

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

What is the FDA product code for NANOLAS ND:YAG OPHTHALMIC LASER?

The FDA product code for NANOLAS ND:YAG OPHTHALMIC LASER is LOI.

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Other records listing Biophysic Medical, Inc. 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.

K953399NEEDLE OR CUTTERK893035OPHTHASCAN 'S' MINI-AK890509INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEMK884595OPHTHASCAN MINI-BK884456STERILE DISPOSABLE ENDOCULAR PROBEK883719INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM

View all 11 devices →

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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