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FDA 510(k)

NATURALASE CO2 LASER SYSTEM

K-Number: K110333 · 2012-04-12

ApplicantFocus Medical, LLC
Decision Date2012-04-12
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NATURALASE CO2 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Focus Medical, LLC. It received FDA 510(k) clearance on 2012-04-12 under 510(k) number K110333. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATURALASE CO2 LASER SYSTEM?

NATURALASE CO2 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-12. The listed applicant is Focus Medical, LLC. The 510(k) number is K110333.

When did NATURALASE CO2 LASER SYSTEM receive FDA 510(k) clearance?

NATURALASE CO2 LASER SYSTEM received FDA 510(k) clearance on 2012-04-12, under 510(k) number K110333.

Who is the listed applicant for NATURALASE CO2 LASER SYSTEM?

The FDA 510(k) record lists Focus Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NATURALASE CO2 LASER SYSTEM?

The FDA product code for NATURALASE CO2 LASER SYSTEM is ONG.

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Other records listing Focus Medical, LLC as applicant

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.

K152737Lite TouchK152529NaturaLase CO2 Laser SystemK101152NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810K041829FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTSK032667FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)K031828NATURALASE LP ND:YAG LASER

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Related Devices (Code: ONG)

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.

K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.K244060eCO2 3DLutronic CorporationK251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.K233550MOSAIC 3D (Surgical Laser)Lutronic AestheticK223871Miria Skin Treatment SystemAVAVA, Inc.

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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