FDA 510(k) clearance · back to tracker

ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY

Surgilase, Inc. cleared K875042 on 1988-06-24, decision: substantially equivalent

K-number

K875042

Sponsor

Surgilase, Inc.

Device

ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY

Class

Class III

Decision

Substantially Equivalent

Decision date

1988-06-24

Product code

LKW

Advisory committee

Unknown

Medical specialty

Unknown

Regulation number

Official FDA record

Open K875042on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.