Tzoar 207 Negative Pressure Wound Therapy (NPWT) System— 510(k) K202898

Name: FDA 510(k) clearance K202898
Creator: U.S. Food and Drug Administration
Published: 2021-12-30

Substantially Equivalent

Lightstone Medical Products (Ningbo) Co, Ltd.

FDA 510(k) clearance K202898 for Tzoar 207 Negative Pressure Wound Therapy (NPWT) System, Substantially Equivalent on 2021-12-30. Applicant: Lightstone Medical Products (Ningbo) Co, Ltd.. Device class: 2.

Clearance details

Applicant: Lightstone Medical Products (Ningbo) Co, Ltd.
Product code: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2020-09-29
Decision date: 2021-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMP

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K261338 — RENASYS DYNAFLOW Kit (66807741)2026-09-11
K253263 — ConvaVAC Negative Pressure Wound Therapy System2026-06-24
K253199 — CURASYS 2 (EMDN0003)2026-06-23
K260646 — RENASYS EDGE (66803126)2026-05-27
K261291 — Nisus NPWT Canister 500-mL (CPC-500)2026-05-21

Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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