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FDA 510(k)

ICOONE Laser Med (also referred to as ICOONE Medical laser)

K-Number: K211272 · 2021-06-22

ApplicantI-Tech Industries Srl
Decision Date2021-06-22
Product CodeNUV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ICOONE Laser Med (also referred to as ICOONE Medical laser) is a medical device manufactured by I-Tech Industries Srl. It received FDA 510(k) clearance on 2021-06-22 under approval number K211272. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICOONE Laser Med (also referred to as ICOONE Medical laser)?

ICOONE Laser Med (also referred to as ICOONE Medical laser) is a medical device that received FDA 510(k) clearance on 2021-06-22. It is manufactured by I-Tech Industries Srl. The 510(k) number is K211272.

When was ICOONE Laser Med (also referred to as ICOONE Medical laser) approved by the FDA?

ICOONE Laser Med (also referred to as ICOONE Medical laser) received FDA 510(k) clearance on 2021-06-22, under approval number K211272.

What company makes ICOONE Laser Med (also referred to as ICOONE Medical laser)?

ICOONE Laser Med (also referred to as ICOONE Medical laser) is manufactured by I-Tech Industries Srl.

What is the FDA product code for ICOONE Laser Med (also referred to as ICOONE Medical laser)?

The FDA product code for ICOONE Laser Med (also referred to as ICOONE Medical laser) is NUV.

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Related PubMed Literature

PMID: 40920948 [The internal condom: overview, practical aspects and analysis of the barriers to its use]. Medecine sciences : M/S (2025)

Other Devices by I-Tech Industries Srl

K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)

Related Devices (Code: NUV)

K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd. K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl K231092T-SHAPE 2B&M S.R.L. Marketing Nel Benessere

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.

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