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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Medical Bio Care Sweden AB · Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time
209 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023081PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIRMedical Bio Care Sweden AB2002-12-16900
K022378PLASMALITE PULSED LIGHT SYSTEMMedical Bio Care Sweden AB2002-10-18880
K022568PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF Medical Bio Care Sweden AB2002-08-29270
K022569PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF Medical Bio Care Sweden AB2002-08-29270
K013365PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LMedical Bio Care Sweden AB2002-01-08900
K013366PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIRMedical Bio Care Sweden AB2002-01-08900
K010927MODIFICATION TO PROLITE PULSED LIGHT SYSTEMMedical Bio Care Sweden AB2001-06-19830
K010928PROLITE VL PULSED LIGHT SYSTEMMedical Bio Care Sweden AB2001-06-19830
K000929PROLITE PULSED LIGHT SYSTEMMedical Bio Care Sweden AB2000-10-172090
K002072PROLITE VL PULSED LIGHT SYSTEMMedical Bio Care Sweden AB2000-09-11660

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda