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Scintillant Surgical Light Model 2644-01-0001

by Engineered Medical Solutions Co., LLC

510(k) K071180

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071180 Date20 Jun 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FTD
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Scintillant Surgical Light Model 2644-01-0001 is a surgical lamp designed to provide focused illumination during operative procedures. It is classified as a Lamp, Surgical under FDA nomenclature and is intended for use in general and plastic surgery settings. The device delivers high-intensity light to enhance visibility and precision in sterile environments, supporting critical surgical tasks.

This device is supplied as a reusable medical instrument and is regulated under 21 CFR 878.4580 with an FDA 510(k) clearance (K071180) granted under the Traditional clearance type. It is classified as Class II and falls under the FTD (Fiber Optic and Laser Surgical Devices) product code. The device is intended for use in operating rooms and surgical suites, where its illumination aids in procedures within the scope of general and plastic surgery.

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