510(k) · Cleared
ClearedCell Robotics Ultra-Light Peel Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cell Robotics, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 11, 2002 as substantially equivalent to K954013 (Schwartz Electro-Optics, Inc., 1996) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Sep 11, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K954013 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK021946 Cell Robotics Ultra-Light Peel Laser SystemCell Robotics, Inc. · 2002
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) | K021946 | Cell Robotics Ultra-Light Peel Laser System | Cell Robotics, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K954013 | Trilase 2940 Erbium LaserSummary page 1…d, Laser 79-GEX 21 CFR878-48 Legally Marketed Predicale Schwartz Electro-Optics TriLase2940, I(# 954013 Device: Cell Robotics Er:YAG Laser System, K# 970461 Asceplion-Meditec… | 1996 |
| * | K970461 | Cell Robotics ER: Yag Surgical LaserSummary page 1…21 CFR878-48 Legally Marketed Predicale Schwartz Electro-Optics TriLase2940, I(# 954013 Device: Cell Robotics Er:YAG Laser System, K# 970461 Asceplion-Meditec Dermastar Er:YAG Laser System, R#014057 Descr… | 1997 |
| * | K014057 | Dermastar ER:Yag Laser SystemSummary page 1…Cell Robotics Er:YAG Laser System, K# 970461 Asceplion-Meditec Dermastar Er:YAG Laser System, R#014057 Description of the Device The Cell Robotics Ultra-Light Laser System is an Er:YAG laser p… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
- 13 other devices also cite its predicate K954013.
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 Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021946: Cell Robotics Ultra-Light Peel Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021946
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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