GIRAFFE BLUE SPOT PT LITE— 510(k) K120820

Substantially Equivalent

Lumitex, Inc.

FDA 510(k) clearance K120820 for GIRAFFE BLUE SPOT PT LITE, Substantially Equivalent on 2012-06-08. Applicant: Lumitex, Inc.. Device class: 2.

Clearance details

Applicant: Lumitex, Inc.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2012-03-19
Decision date: 2012-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Strongsville, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBI

K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)2026-01-15
K243372 — BiliWrap2025-05-29
K210289 — Infant Phototherapy Equipment2021-05-28
K200031 — Neonatal Phototherapy System2020-10-05
K190899 — bili-hut2019-09-05

More clearances from Lumitex, Inc.

K053568 — BILISOFT PHOTOTHERAPY SYSTEM2006-04-17
K912747 — LULMITEX NEONATAL TRANSILLUMINATOR1991-12-24

Recalls naming K120820

K-number listed on FDA's recall record

Z-0923-2020 — Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M1225064, M1225024, M1231622, M1236303, M1238489, M1238490, M1238492, M1238493, M1238495, M1238499, M1238503, M1238505, M1238507, M1238508, 2063860-001, 2063862-001, 2063870-001, 2063873-001, 2063874-001, 2071393-001, 2080916-001, 2089424-001Class II·Terminated·Lumitex Inc·20191211

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120820.

Data sourced from openFDA. This site is unofficial and independent of the FDA.