Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE

K-Number: K880930 · 1988-05-31

ApplicantCopper Lasersonics, Inc.
Decision Date1988-05-31
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE is the device name listed in this FDA 510(k) record. The listed applicant is Copper Lasersonics, Inc.. It received FDA 510(k) clearance on 1988-05-31 under 510(k) number K880930. 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 MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE?

MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE is a medical device that received FDA 510(k) clearance on 1988-05-31. The listed applicant is Copper Lasersonics, Inc.. The 510(k) number is K880930.

When did MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE receive FDA 510(k) clearance?

MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE received FDA 510(k) clearance on 1988-05-31, under 510(k) number K880930.

Who is the listed applicant for MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE?

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

What is the FDA product code for MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE?

The FDA product code for MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE is HHR.

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, LLCK880991LASER OPTICAL CATHETER SYSTEMMedline Industries, 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.

↑