GEX: Powered Laser Surgical Instrument

510(k) review time for GEX

Across 526 510(k) clearances under GEX decided from 2018-01-01 to 2026-10-06, the median was 90 days from FDA receipt to decision. Half took between 62 and 173 days, and 80% were decided within 197 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, GEX, decisions 2018-01-01 to 2026-10-06 (n = 526)

Fastest	9
25th percentile	62
Median	90
75th percentile	173
80th percentile	197
90th percentile	266
Slowest	806

Median days by decision year, GEX (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.

Year	Median days	n
2018	78	51
2019	88	41
2020	90	52
2021	123	53
2022	152	60
2023	87	52
2024	90	82
2025	90	83
2026 (to 10-06, partial)	89	52

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

GEX in the public FDA record

Records naming GEX, from openFDA (snapshot of 2026-09-15)

510(k) clearances, all years	2,878
Device recalls	201
Establishment listings	1,832
GUDID device identifiers	6,574

Counts of records, not of devices or events. Adverse event reports for GEX are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite GEX

5 FDA recognized consensus standards cite GEX, among them ANSI IES RP-27.2-00/R17; IEC 62471 First edition 2006-07; IEC 60825-1 Edition 2.0 2007-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

• 12-102 ANSI IES RP-27.2-00/R17 — Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
• 12-249 IEC 62471 First edition 2006-07 — Photobiological safety of lamps and lamp systems
• 12-273 IEC 60825-1 Edition 2.0 2007-03 — Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)]
• 12-297 ANSI IES RP-27.1-2015 — Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
• 12-321 ANSI IES RP-27.3-17 — Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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