BIOLIGHT BIODYNAM— 510(k) K130866
Substantially EquivalentBiolight AB
FDA 510(k) clearance K130866 for BIOLIGHT BIODYNAM, Substantially Equivalent on 2013-10-25. Applicant: Biolight AB. Device class: 2.
Clearance details
- Applicant
- Biolight AB
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Stockholm, SE
Recent devices under product code ILY
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- K223642 — LED Lip Perfector, model: ZC-05
- K221189 — OLIZ LTB-1000A
Adverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.