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510(k) Data Aggregation
K Number
K231893Device Name
LOWTEM Crystal 120
Manufacturer
LowTem Co., Ltd.
Date Cleared
2024-09-18
(448 days)
Product Code
MLR
Regulation Number
880.6860Why did this record match?
Applicant Name (Manufacturer) :
LowTem Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LOWTEM Crystal 120 Sterilizer System is indicated to sterilize pre-cleaned and dried reusable medical devices with nonabsorbable materials. The Crystal 120 sterilizer's Standard cycle can sterilize:
- Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors,
- Medical devices with single stainless-steel lumen with:
An inside diameter of 1mm or larger and a length of 125mm or shorter
An inside diameter of 2mm or larger and a length of 250mm or shorter
An inside diameter of 3mm or larger and a length of 400mm or shorter
* The validation testing for this lumen size was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
- Contra-indication: It is contraindicated to sterilize single usable medical devices made up with absorbable materials such as cellulose or wood.
- Intended user: trained nurse level or higher level of healthcare providers
The validated maximum load conditions
Total weight:
The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg(19.6lbs).
Usage of sterilization pouch:
The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.
Device Description
The LOWTEM Crystal 120 low-temperature vaporized hydrogen peroxide sterilizer is a selfcontained stand-alone device, using vaporized hydrogen peroxide as the sterilant.
The LOWTEM Crystal 120 includes the LCD touch monitor, Hydrogen Peroxide Supply (HPS) Unit, Sterilization Chamber Door, and Printer on the front of the Sterilizer.
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