BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200— 510(k) K101417

Substantially Equivalent

Medipurpose Pte. , Ltd.

FDA 510(k) clearance K101417 for BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200, Substantially Equivalent on 2010-10-19. Applicant: Medipurpose Pte. , Ltd..

Clearance details

Applicant: Medipurpose Pte. , Ltd.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 2010-05-20
Decision date: 2010-10-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Alpharetta, GA, US

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Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.