FDA 510(k)

Smile-100 System

K-Number: K212965 · 2022-03-10

ApplicantNiramai Health Analytix Private Limited

Decision Date2022-03-10

Product CodeLHQ

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Smile-100 System is the device name listed in this FDA 510(k) record. The listed applicant is Niramai Health Analytix Private Limited. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K212965. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smile-100 System?

Smile-100 System is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Niramai Health Analytix Private Limited. The 510(k) number is K212965.

When did Smile-100 System receive FDA 510(k) clearance?

Smile-100 System received FDA 510(k) clearance on 2022-03-10, under 510(k) number K212965.

Who is the listed applicant for Smile-100 System?

The FDA 510(k) record lists Niramai Health Analytix Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smile-100 System?

The FDA product code for Smile-100 System is LHQ.

Related Devices (Code: LHQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253911Derma-2Neko Health AB K232462ThermPix Thermovisual CameraUsa Therm, Inc.K213650ThermPix Thermovisual CameraUsa Therm, Inc.K212412IRIS-XPMedicore Co., Ltd.K200999Thermidas IR System (ThIR-A615)Thermidas Americas, Inc.K181716InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.