510(k) · Cleared
ClearedPowerlite 600 EX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Preswede AB · GEX Powered Laser Surgical Instrument
Cleared on Mar 16, 2004 as substantially equivalent to K030423 (Preswede AB, 2003) and 1 other predicate after an 88-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Mar 16, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K910422 (1992). 52 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 2 generations backK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- 1 generation backK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
- This deviceK033933 Powerlite 600 EX SystemPreswede AB · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −6 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −4 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −3 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −2 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| −1 | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems | Lumenis | 2003 | — |
| 0 (this device) | K033933 | Powerlite 600 EX System | Preswede AB | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K030423 | Powerlite 600 EP SystemSummary page 1…Contact: Mr. John Wilhelmsson, President 2. Name of the Device: Powerlite 600® EX System. 3. Predicate Device Information: K# 030423, Powerlite600® EP System, Preswede AB, Sweden K#030527, Vasculigrit, Model SR - Lumenis Family of Intense Pulsed-Light… | 2003 |
| * | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsSummary page 1…e of the Device: Powerlite 600® EX System. 3. Predicate Device Information: K# 030423, Powerlite600® EP System, Preswede AB, Sweden K#030527, Vasculigrit, Model SR - Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems, Lumenis, Inc. 4.… | 2003 |
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 12 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 52 ancestors has a recall of any class.
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?
An intense pulsed light, the Powerlite 6000 EX System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows: * The treatment of tattoos; * The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); * The…
Read the full statement (128 words)
An intense pulsed light, the Powerlite 6000 EX System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
* The treatment of tattoos;
* The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
* The treatment of cutaneous lesions including warts, scars and striae;
* The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema or rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
* The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033933 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033933: Powerlite 600 EX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033933
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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