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Found 5 results
510(k) Data Aggregation
K Number
K251450Device Name
Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)
Manufacturer
Shenzhen Desida Technology Co., Ltd.
Date Cleared
2025-06-06
(28 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Desida Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
Device Description
Not Found
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K Number
K244033Device Name
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
Manufacturer
Shenzhen Desida Technology Co., Ltd.
Date Cleared
2025-05-16
(137 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Desida Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment.
Device Description
Electric Nasal Aspirator consists of silicone nozzle which has three models (conical nozzle, flat nozzle, angled nozzle), collection cup, air tube, tweezers, charging cable-USB and aspirator body. The Electric Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line.
The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
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K Number
K233901Device Name
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
Manufacturer
Shenzhen Desida Technology Co., Ltd.
Date Cleared
2024-03-20
(100 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Desida Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is ued in a home environment.
Device Description
The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. It consists of main unit, and suction working together as one unit. The Baby Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The recharged from the external power adapter(not included in this device) through the provided charging line. The user interface consists of buttons and the user can control the vacuum pressure through the button.
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K Number
K221643Device Name
Hair Removal Device (Model: IPL-D26, IPL-D19)
Manufacturer
Shenzhen Desida Technology Co., Ltd.
Date Cleared
2022-10-21
(137 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Desida Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hair Removal Devices (models IPL-D26 and IPL-D19) are over the counter devices intended for the removal of unwanted hair. The devices are intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Device Description
The Hair Removal Devices (Model:IPL-D26,IPL-D19) are pulsed light hair removal devices. The IPL-D26 and IPL-D19 models use the same components and have the same features except for their color. The IPL-D26 is white and IPLD19 is red. The device uses light pulses to produce hair removal, and the effect of the device is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The IPL-D26 and IPL-D19 devices are each composed of a hand held applicator and an external power supply. Each applicator contains a xenon lamp, a skin color sensor and a skin proximity sensor. The xenon lamp emits the pulsed light flashes to produce hair removal. The skin color sensor is to ensure that the light will be emitted only to skin color appropriate for the device. The contact sensor is to ensure that the light pulses will not be emitted unless the applicator in full contact with the skin. The spot size (treatment area) in the Hair Removal Device devices is 3 cm²
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K Number
K221635Device Name
IPL sapphire ice cooling hair remove device
Manufacturer
Shenzhen Desida Technology Co., Ltd.
Date Cleared
2022-08-31
(86 days)
Product Code
OHT, ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Desida Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.
Device Description
The IPL sapphire cooling hair remove device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the light pulse.
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