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InstaClear Lens Cleaner

by Gyrus Acmi, Inc.

510(k) K152531

InstaClear Lens Cleaner is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K152531 on 15 Jan 2016, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK152531 Date15 Jan 2016ClearedStatusActive

Official records

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1888-2024 FDA Class II initiated 3 Apr 2024

    Potential for distal end of the sheath to break off during a procedure.

    • Ongoing Z-1368-2024 FDA Class II initiated 16 Jan 2024

    Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU

Timeline

3 dated events

  1. Cleared FDA 510(k) K152531
  2. Recall initiated FDA recalls Z-1368-2024
  3. Recall initiated FDA recalls Z-1888-2024

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  • Withdrawn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
EOB
Device class
Class II
Regulation
21 CFR Part 874.4760
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

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

Cites

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

Devices cleared under K152531

24 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 K152531
UDI-DISize and differences
InstaClear LCS1500UNOL
Gyrus Acmi, Inc.
LCS1500UNOL00821925040137
Single use: yes
On the market
InstaClear LCS1530BTOL
Gyrus Acmi, Inc.
LCS1530BTOL00821925040151
Single use: yes
On the market
InstaClear LCS1530TPOL
Gyrus Acmi, Inc.
LCS1530TPOL00821925040144
Single use: yes
On the market
InstaClear LCS1545BTOL
Gyrus Acmi, Inc.
LCS1545BTOL00821925040175
Single use: yes
On the market
InstaClear LCS1545TPOL
Gyrus Acmi, Inc.
LCS1545TPOL00821925040168
Single use: yes
On the market
InstaClear LCS1570BTOL
Gyrus Acmi, Inc.
LCS1570BTOL00821925040199
Single use: yes
On the market
InstaClear LCS1570TPOL
Gyrus Acmi, Inc.
LCS1570TPOL00821925040182
Single use: yes
On the market
InstaClear LCS1800UNST
Gyrus Acmi, Inc.
LCS1800UNST00821925040069
Single use: yes
On the market
InstaClear LCS1830BTST
Gyrus Acmi, Inc.
LCS1830BTST00821925040083
Single use: yes
On the market
InstaClear LCS1830TPST
Gyrus Acmi, Inc.
LCS1830TPST00821925040076
Single use: yes
On the market
InstaClear LCS1845BTST
Gyrus Acmi, Inc.
LCS1845BTST00821925040106
Single use: yes
On the market
InstaClear LCS1845TPST
Gyrus Acmi, Inc.
LCS1845TPST00821925040090
Single use: yes
On the market
InstaClear LCS1870BTST
Gyrus Acmi, Inc.
LCS1870BTST00821925040120
Single use: yes
On the market
InstaClear LCS1870TPST
Gyrus Acmi, Inc.
LCS1870TPST00821925040113
Single use: yes
On the market
InstaClear LCS4K00UNOL
Gyrus Acmi, Inc.
LCS4K00UNOL00821925041462
Single use: yes
On the market
InstaClear LCS4K30BTOL
Gyrus Acmi, Inc.
LCS4K30BTOL00821925041486
Single use: yes
On the market
InstaClear LCS4K30TPOL
Gyrus Acmi, Inc.
LCS4K30TPOL00821925041479
Single use: yes
On the market
InstaClear LCS4K45BTOL
Gyrus Acmi, Inc.
LCS4K45BTOL00821925041509
Single use: yes
On the market
InstaClear LCS4K45TPOL
Gyrus Acmi, Inc.
LCS4K45TPOL00821925041493
Single use: yes
On the market
InstaClear LCS4K70BTOL
Gyrus Acmi, Inc.
LCS4K70BTOL00821925041523
Single use: yes
On the market
InstaClear LCS4K70TPOL
Gyrus Acmi, Inc.
LCS4K70TPOL00821925041516
Single use: yes
On the market
InstaClear LCTS100S
Gyrus Acmi, Inc.
LCTS100S00821925040052
Single use: yes
On the market
Olympus LCCONS100
Gyrus Acmi, Inc.
LCCONS10000821925040038
Single use: no
On the market
Olympus LCFP100
Gyrus Acmi, Inc.
LCFP10000821925040045
Single use: no
On the market

Similar devices

Other devices filed under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

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