LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.— 510(k) K802381
Substantially EquivalentFibra Sonics, Inc.
FDA 510(k) clearance K802381 for LEWICKY ANTERIOR CHAMBER MAINTEN. SYS., Substantially Equivalent on 1980-12-17. Applicant: Fibra Sonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Fibra Sonics, Inc.
- Product code
- Code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code HQC
view all- K261264 — Stellaris Elite vision enhancement system +7 more
- K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
- K250501 — System Sophi
- K243395 — MICOR 700 with Auto I/A
- K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
More clearances from Fibra Sonics, Inc.
view all- K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
- K984199 — EXONIX
- K984143 — FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
- K983199 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
- K980930 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
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.