510(k) · Cleared
ClearedLad, Model Lad-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norwood Abbey, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 8, 2003 as substantially equivalent to K974855 (Iomed, Inc., 1998) and 1 other predicate after a 266-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jan 8, 2003
- Review
- 266 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K934335 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK934335 Phoresor II Auto, Model PM800 ModificationIomed, Inc. · 1994
- 1 generation backK974855 Phoresor II, Model PM900Iomed, Inc. · 1998
- This deviceK021222 Lad, Model Lad-01Norwood Abbey, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK040525 Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic…Sontra Medical, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040525Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000Sontra Medical, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934335 | Phoresor II Auto, Model PM800 Modification | Iomed, Inc. | 1994 | — |
| −1 | K974855 | Phoresor II, Model PM900 | Iomed, Inc. | 1998 | — |
| 0 (this device) | K021222 | Lad, Model Lad-01 | Norwood Abbey, Ltd. | 2003 | — |
| +1 | K040525 | Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model… | Sontra Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974855 | Phoresor II, Model PM900Summary page 1…and in dermatology Proprietary Name: LAD, model LAD-0 1 1.3 Predicate Devices Currently marketed Phoresor I1 Model 900 (K974855)and the LaserLancet LB IO0 (K980538)were selected as the predicate devices for this submission. 1.4 Description of… | 1998 |
| * | K980538 | Laser Lancet LB100Summary page 1…roprietary Name: LAD, model LAD-0 1 1.3 Predicate Devices Currently marketed Phoresor I1 Model 900 (K974855)and the LaserLancet LB IO0 (K980538)were selected as the predicate devices for this submission. 1.4 Description of the Device The Norwood Abbey Model… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040525 | Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000 | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K040525 (Sontra Medical, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K974855.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The LAD is indicated for the ablation of the outer layer of the skin prior to the
application of OTC topical 4% lidocaine cream, for local dermal anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021222 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021222: Lad, Model Lad-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021222
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026