Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COMPACT S, COMPACT S (LED)

K-Number: K170104 · 2017-12-27

ApplicantDmetec.Co., Ltd.
Decision Date2017-12-27
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMPACT S, COMPACT S (LED) is a medical device manufactured by Dmetec.Co., Ltd.. It received FDA 510(k) clearance on 2017-12-27 under approval number K170104. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPACT S, COMPACT S (LED)?

COMPACT S, COMPACT S (LED) is a medical device that received FDA 510(k) clearance on 2017-12-27. It is manufactured by Dmetec.Co., Ltd.. The 510(k) number is K170104.

When was COMPACT S, COMPACT S (LED) approved by the FDA?

COMPACT S, COMPACT S (LED) received FDA 510(k) clearance on 2017-12-27, under approval number K170104.

What company makes COMPACT S, COMPACT S (LED)?

COMPACT S, COMPACT S (LED) is manufactured by Dmetec.Co., Ltd..

What is the FDA product code for COMPACT S, COMPACT S (LED)?

The FDA product code for COMPACT S, COMPACT S (LED) is ELC.

Related Devices (Code: ELC)

K161639Y-MICMicron Corporation K160905Sonendo GentleWave SystemSonendo, Inc. K153157Sonendo Gentle Wave SystemSonendo, Inc. K163414Ultrasonic scalerNanning VV Dental Co., Ltd. K171150AW-100Micron Corporation K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A

Official Source

View on FDA Database →

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

↑