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510(k) K231893

LOWTEM Crystal 120 by Lowtem Co., Ltd. — Product Code MLR

K231893 is an FDA 510(k) premarket notification submitted by Lowtem Co., Ltd. for the device "LOWTEM Crystal 120". The FDA issued a decision of Substantially Equivalent on September 18, 2024. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2024
Date Received
June 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

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FDA data resources