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FDA Medical Device Recalls (openFDA)

LightMed USA Inc: Model LightLas 532 Opthalmic Photocoagulator Laser

Recall number
Z-0228-04
Recalling firm
LightMed USA Inc
Product
Model LightLas 532 Opthalmic Photocoagulator Laser
Status
Terminated
Initiated
2003-11-11
Posted
2003-12-17
Terminated
2003-12-16
Reason
Firm needed to include calibration procedures in user guide.
Root cause
Other
Action
Firm fedexed new user manuals with calibration procedures to each consignee on 11/11/2003.
Quantity
2
Distribution
CA, GA
Lot, serial or model codes
All codes
510(k) numbers
["K990075","K010372"]
PMA numbers
not on file
Product code
HQF
Firm FEI
3003976404
Firm city
San Clemente
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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