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FDA 510(k)

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

K-Number: K864946 · 1988-01-28

ApplicantBio Quantum Technologies, Inc.
Decision Date1988-01-28
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED 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 1988-01-28 under 510(k) number K864946. The device is classified under product code HHR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE is a medical device that received FDA 510(k) clearance on 1988-01-28. The listed applicant is Bio Quantum Technologies, Inc.. The 510(k) number is K864946.

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

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE received FDA 510(k) clearance on 1988-01-28, under 510(k) number K864946.

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

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

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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-550SK864887ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SUK864948ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USEK840406MICROSURGICAL CO2 LASER SYS - 4100K837110MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM

Related Devices (Code: HHR)

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.

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.K874615LASER CANNISTER FILTERMedical Marketing, Inc.K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLCK880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, 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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