510(k) · Cleared
ClearedLotus II Pulsed ER: Yag Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laseroptek Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on May 15, 2009 as substantially equivalent to K014057 (Asclepion-Meditec AG, 2002) and 1 other predicate after a 192-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- May 15, 2009
- Review
- 192 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954013 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
- 3 generations backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
- 2 generations backK980361 Dermablate ER: Yag Laser SystemAesculap-Meditec North America · 1998
- 1 generation backK014057 Dermastar ER:Yag Laser SystemAsclepion-Meditec AG · 2002
- This deviceK083253 Lotus II Pulsed ER: Yag Laser SystemLaseroptek Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK182045 Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954013 | Trilase 2940 Erbium Laser | Schwartz Electro-Optics, Inc. | 1996 | — |
| −3 | K961748 | Medlite/Erbium Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −2 | K980361 | Dermablate ER: Yag Laser System | Aesculap-Meditec North America | 1998 | — |
| −1 | K014057 | Dermastar ER:Yag Laser System | Asclepion-Meditec AG | 2002 | — |
| 0 (this device) | K083253 | Lotus II Pulsed ER: Yag Laser System | Laseroptek Co., Ltd. | 2009 | — |
| +1 | K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | Laseroptek Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K014057 | Dermastar ER:Yag Laser SystemSummary page 2…510(K) Application Lotus IIPulsed Er:YAG Laser System Legally Marketed Predicate Devices: * DermaStarEr:YAG Laser System (K014057) by Asclepion-Meditec AG MCL 3oDermablateE… | 2002 |
| * | K042968 | MCL 30 Dermablate ER:Yag Laser SystemSummary page 2…Asclepion-Meditec AG MCL 3oDermablateEr:YAG Laser System (K042968) by Cynosure, Inc. Description of the Lotus II Pulsed The Lotus LI laser system is an Erbium:YAG laser Er:YAG Laser System:… | 2004 |
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 |
|---|---|---|---|
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | 2018 | 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 13 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K182045 (Laseroptek Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K014057.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Lotus II Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083253: Lotus II Pulsed ER: Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083253
Report an extraction error
Are you the manufacturer?
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