ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY— 510(k) K875039

Name: FDA 510(k) clearance K875039
Creator: U.S. Food and Drug Administration
Published: 1988-04-13

Substantially Equivalent

Surgilase, Inc.

FDA 510(k) clearance K875039 for ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY, Substantially Equivalent on 1988-04-13. Applicant: Surgilase, Inc.. Device class: 2.

Clearance details

Applicant: Surgilase, Inc.
Product code: Code LNK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1987-12-07
Decision date: 1988-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warwick, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNK

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K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM1993-05-21
K901723 — MDL-2000 LASERTRIPTER1990-07-13
K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.1988-07-12
K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.1988-07-12
K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE1988-04-14

More clearances from Surgilase, Inc.

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K932421 — SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE1993-10-15
K924664 — SURGILASE FIBERLASE CO2 LASER WAVEGUIDE1993-04-15
K905006 — SURGILASE SL 150 SURGICAL LASER SYSTEM1991-02-21
K904203 — SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM1990-12-07
K902211 — SURGILASE YAG 100 SURGICAL LASER SYSTEM1990-06-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.