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FDA 510(k)

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE

K-Number: K864948 · 1987-03-30

ApplicantBio Quantum Technologies, Inc.
Decision Date1987-03-30
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE is the device name listed in this FDA 510(k) record. The listed applicant is Bio Quantum Technologies, Inc.. It received FDA 510(k) clearance on 1987-03-30 under 510(k) number K864948. The device is classified under product code LNK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE?

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE is a medical device that received FDA 510(k) clearance on 1987-03-30. The listed applicant is Bio Quantum Technologies, Inc.. The 510(k) number is K864948.

When did ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE receive FDA 510(k) clearance?

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE received FDA 510(k) clearance on 1987-03-30, under 510(k) number K864948.

Who is the listed applicant for ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE?

The FDA 510(k) record lists Bio Quantum Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE?

The FDA product code for ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE is LNK.

Related Clinical Trials

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.

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Other records listing Bio Quantum Technologies, Inc. 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.

K934089BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550SK864946ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USEK864887ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SUK840406MICROSURGICAL CO2 LASER SYS - 4100K837110MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM

Related Devices (Code: LNK)

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.

K925395TECHNOMED PULSOLITH 4000 LASER SYSTEMTeknomed, Inc.K901723MDL-2000 LASERTRIPTERCandela Laser Corp.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.Minnesota Laser Corp.K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.Minnesota Laser Corp.K880256MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USESharplan Lasers, Inc.K880193MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USESharplan Lasers, Inc.

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.

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