Medical Bio Care Sweden AB: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Medical Bio Care Sweden AB” (first 2000, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 10 | 10 |
Review panels
Most recent Medical Bio Care Sweden AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023081 | PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) | GEX | 2002-12-16 | 90 |
| K022378 | PLASMALITE PULSED LIGHT SYSTEM | GEX | 2002-10-18 | 88 |
| K022569 | PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS | GEX | 2002-08-29 | 27 |
| K022568 | PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR | GEX | 2002-08-29 | 27 |
| K013366 | PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR | GEX | 2002-01-08 | 90 |
| K013365 | PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS | GEX | 2002-01-08 | 90 |
| K010928 | PROLITE VL PULSED LIGHT SYSTEM | GEX | 2001-06-19 | 83 |
| K010927 | MODIFICATION TO PROLITE PULSED LIGHT SYSTEM | GEX | 2001-06-19 | 83 |
| K000929 | PROLITE PULSED LIGHT SYSTEM | GEX | 2000-10-17 | 209 |
| K002072 | PROLITE VL PULSED LIGHT SYSTEM | GEX | 2000-09-11 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Bio Care Sweden AB.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Bio Care Sweden AB?
FDA lists 10 510(k) clearances under the applicant name “Medical Bio Care Sweden AB” (first 2000, latest 2002), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medical Bio Care Sweden AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Bio Care Sweden AB is 86 days.
Which FDA product codes appear under Medical Bio Care Sweden AB?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 10).
Next steps
- See all 10 Medical Bio Care Sweden AB clearances with predicates and recalls
- Run predicate analysis for product code GEX, Medical Bio Care Sweden AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.