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Slit Lamp (Hs-5000 +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093639

by Huvitz Co., Ltd.

Identifiers

510(k) Number
K093639 FDA 510(k)
FDA Product Code
HJO FDA 510(k)
Models / Variants
Hs-5000 FDA 510(k)
Hs-5500 FDA 510(k)
Hs-7500 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.1850 FDA 510(k)
Regulation Number
886.1850 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Slit Lamp (Hs-5000 +2 more) by Huvitz Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Huvitz Co., Ltd.

Sources (1)

  • FDA 510(k) K093639 24 fields · synced Jun 18, 2026