510(k) Report

FDA product code · Ophthalmic

Aid, Surgical, Viscoelastic

LZPClass III21 CFR 886.4275PMA required13 decisions since 198319 recalls

13 FDA decisions since 1983. 19 recalls name this code, 1 of them Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ophthalmic panel

Twenty years of LZP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · LZP

13in 2025

2007: 82008: 212009: 112010: 162011: 132012: 292013: 212014: 172015: 112016: 122017: 182018: 82019: 52020: 132021: 152022: 82023: 132024: 102025: 132026 (partial year): 7
2007high 29 (2012) · low 5 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZP

Too few LZP 510(k)s in any year since 2007 to give a median.

Recalls per year · LZP

1in 2019

2008: 12010: 12013: 1, 1 Class I2014: 12019: 12026 (partial year): 1
2007high 1 (2008) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LZP

64in 2025

2007: 582008: 2032009: 342010: 1572011: 1062012: 1402013: 832014: 1192015: 682016: 1362017: 1622018: 1132019: 1562020: 1322021: 1572022: 1842023: 1072024: 762025: 64
2007high 203 (2008) · low 34 (2009)2025

MAUDE reports naming product code LZP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078—058
200821—1203
200911—034
201016—1157
201113—0106
201229—0140
201321—1 (1)83
201417—1119
201511—068
201612—0136
201718—0162
20188—0113
20195—1156
202013—0132
202115—0157
20228—0184
202313—0107
202410—076
202513—064
20267—1—
FIG. 1 — LZP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LZP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 886.4275.