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Leaf Photocoagulator

by Norlase Aps

510(k) K190083

Leaf Photocoagulator is a medical device (FDA Class II; FDA product code HQF, Laser, Ophthalmic) made by Norlase Aps, cleared under FDA 510(k) K190083 on 3 May 2019, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190083 Date3 May 2019ClearedStatusActive

Official records

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  • Withdrawn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
HQF
Device class
Class II
Regulation
21 CFR Part 886.4390
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K190083

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K190083
UDI-DISize and differences
Norlase Leaf photocoagulator N005-9010-03
Norlase Aps
N005-9010-0305700002165411 —On the market
Norlase LEAF photocoagulator N005-9010-Z
Norlase Aps
N005-9010-Z05700002165442 —On the market

Similar devices

Other devices filed under FDA product code HQF (Laser, Ophthalmic).

Other devices from Norlase Aps

See all devices from Norlase Aps →