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FDA 510(k)

NATURALASE LP ND:YAG LASER

K-Number: K031828 · 2003-07-17

ApplicantFocus Medical, LLC
Decision Date2003-07-17
Product CodeGEN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NATURALASE LP ND:YAG LASER 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 2003-07-17 under 510(k) number K031828. The device is classified under product code GEN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATURALASE LP ND:YAG LASER?

NATURALASE LP ND:YAG LASER is a medical device that received FDA 510(k) clearance on 2003-07-17. The listed applicant is Focus Medical, LLC. The 510(k) number is K031828.

When did NATURALASE LP ND:YAG LASER receive FDA 510(k) clearance?

NATURALASE LP ND:YAG LASER received FDA 510(k) clearance on 2003-07-17, under 510(k) number K031828.

Who is the listed applicant for NATURALASE LP ND:YAG LASER?

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 LP ND:YAG LASER?

The FDA product code for NATURALASE LP ND:YAG LASER is GEN.

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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 SystemK110333NATURALASE 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)

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Related Devices (Code: GEN)

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.

K953962FORCEPSBiopsys Medical, Inc.K932385SUTURE REMOVING FORCEPSRocket of London, Ltd.K904723FORCEPSMinto Research & Development, Inc.K911159PALPATION PROBENorthgate Technologies, Inc.K900952GS-1200 GRASPING/EXTRACTING FORCEP, 10MMSolos Endoscopy, Inc.K900951GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIPSolos Endoscopy, 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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