Cleared Traditional

LOWTEM Crystal 120

K231893 · Lowtem Co., Ltd. · General Hospital
Sep 2024
Decision
448d
Days
Class 2
Risk

About This 510(k) Submission

K231893 is an FDA 510(k) clearance for the LOWTEM Crystal 120, a Sterilizer, Chemical (Class II — Special Controls, product code MLR), submitted by Lowtem Co., Ltd. (Daegu-Si, KR). The FDA issued a Cleared decision on September 18, 2024, 448 days after receiving the submission on June 28, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.

Submission Details

510(k) Number K231893 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2023
Decision Date September 18, 2024
Days to Decision 448 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MLR — Sterilizer, Chemical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6860

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