510(k) · Cleared
ClearedLightlance Laser Skin Perforator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innotech USA, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 30, 2002 as substantially equivalent to K983673 (Cell Robotics, Inc., 1999) and 1 other predicate after a 265-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- May 30, 2002
- Review
- 265 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981746 (1998). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK981746 Cell Robotics' LasetteCell Robotics, Inc. · 1998
- This deviceK013021 Lightlance Laser Skin PerforatorInnotech USA, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK172818 LMT-3000Lameditech Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK241646 Ortiv (Ortiv-BL, Ortiv-WH)Mvitro Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981746 | Cell Robotics' Lasette | Cell Robotics, Inc. | 1998 | — |
| 0 (this device) | K013021 | Lightlance Laser Skin Perforator | Innotech USA, Inc. | 2002 | — |
| +1 | K172818 | LMT-3000 | Lameditech Co., Ltd. | 2018 | — |
| +2 | K241646 | Ortiv (Ortiv-BL, Ortiv-WH) | Mvitro Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K983673 | LasetteSummary page 2…§878.4810 Device Class: Class I 3. Substantial Equivalence: The LightLance™ Laser Skin Perforator substantially equivalent to the current, legally marketed LASETTE™ (k983673) and (k981746). The LightLance™ Laser Skin Perforator has the same intended use and general and specific indications as both of p… | 1999 |
| * | K981746 | Cell Robotics' LasetteSummary page 2…vice Class: Class I 3. Substantial Equivalence: The LightLance™ Laser Skin Perforator substantially equivalent to the current, legally marketed LASETTE™ (k983673) and (k981746). The LightLance™ Laser Skin Perforator has the same intended use and general and specific indications as both of predicated Lase… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172818 | LMT-3000 | 2018 | 1 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K172818 (Lameditech Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
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 LightLance™ Laser Skin Perforator is intended to be used for ablation of skin tissue to establish capillary blood access. The LightLance™ Laser Skin Perforator general indication for use is for the perforation of skin to draw capillary blood for screening purposes. The device is specifically indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration in both institutional and home settings
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013021: Lightlance Laser Skin Perforator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013021
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026