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FDA 510(k)

CREAT BRAND I/A PACK CREAT BRAND PHACO PACK

K-Number: K853189 · 1985-09-24

ApplicantAesthetech Corp.
Decision Date1985-09-24
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CREAT BRAND I/A PACK CREAT BRAND PHACO PACK is the device name listed in this FDA 510(k) record. The listed applicant is Aesthetech Corp.. It received FDA 510(k) clearance on 1985-09-24 under 510(k) number K853189. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREAT BRAND I/A PACK CREAT BRAND PHACO PACK?

CREAT BRAND I/A PACK CREAT BRAND PHACO PACK is a medical device that received FDA 510(k) clearance on 1985-09-24. The listed applicant is Aesthetech Corp.. The 510(k) number is K853189.

When did CREAT BRAND I/A PACK CREAT BRAND PHACO PACK receive FDA 510(k) clearance?

CREAT BRAND I/A PACK CREAT BRAND PHACO PACK received FDA 510(k) clearance on 1985-09-24, under 510(k) number K853189.

Who is the listed applicant for CREAT BRAND I/A PACK CREAT BRAND PHACO PACK?

The FDA 510(k) record lists Aesthetech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREAT BRAND I/A PACK CREAT BRAND PHACO PACK?

The FDA product code for CREAT BRAND I/A PACK CREAT BRAND PHACO PACK is HQC.

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Other records listing Aesthetech Corp. 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.

K873940CREAT BRAND O-RISE GENERAL ASPIRATORK873434CREAT BRAND MALAR IMPLANTK843678CREAT BRAND SKIN EXPANDERK841283DISPOSABLE SUCTION TUBING SETK812210CREAT BRAND WAGNER CHIN IMPLANT

Related Devices (Code: HQC)

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.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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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