510(k) · Cleared
ClearedCosmelight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penntack Enterprises, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 31, 2007 as substantially equivalent to K020839 (Lumenis, Inc., 2002) and 3 other predicates after a 226-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Jan 31, 2007
- Review
- 226 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K910422 (1992). 69 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK043255 Ellipse Light SPTDanish Dermatologic Development A/S · 2005
- 2 generations backK052688 Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005
- 1 generation backK060516 Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006
- This deviceK061720 CosmelightPenntack Enterprises, Inc. · 2007
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- 4 generations backK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
- 3 generations backK043255 Ellipse Light SPTDanish Dermatologic Development A/S · 2005
- 2 generations backK052688 Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005
- 1 generation backK060516 Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006
- This deviceK061720 CosmelightPenntack Enterprises, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| −4 | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… | Lumenis, Ltd. | 2003 | — |
| −3 | K043255 | Ellipse Light SPT | Danish Dermatologic Development A/S | 2005 | — |
| −2 | K052688 | Ellipse Flex PPT, Model 9ESF7255 | Danish Dermatologic Development A/S | 2005 | — |
| −1 | K060516 | Ellipse 12PL, Model 9ESL7228 | Danish Dermatologic Development A/S | 2006 | — |
| 0 (this device) | K061720 | Cosmelight | Penntack Enterprises, Inc. | 2007 | — |
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 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 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? (4)
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 |
|---|---|---|---|
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…keted The Cosmelight is substantially equivalent to the following currently Predicate Devices: marketed devices: Lumenis Inc LPL Quantumn, K020839 Palomar Inc. EsteLux, K020453 McCue Plc. McCue Energist ULTRA, K040659… | 2002 |
| * | K020453 | Palomar Estelux Pulsed Light System and Palomar CoolrollerSummary page 1…the following currently Predicate Devices: marketed devices: Lumenis Inc LPL Quantumn, K020839 Palomar Inc. EsteLux, K020453 McCue Plc. McCue Energist ULTRA, K040659 DDD AIS, Ellipse I2PL, K(060516 Sys… | 2002 |
| * | K040659 | Mccue PLC Energist Ultra Variable Pulsed Light SystemSummary page 1…Lumenis Inc LPL Quantumn, K020839 Palomar Inc. EsteLux, K020453 McCue Plc. McCue Energist ULTRA, K040659 DDD AIS, Ellipse I2PL, K(060516 System Description: The Cosmnefight Intense Pulsed Light System is co… | 2004 |
| * | K060516 | Ellipse 12PL, Model 9ESL7228Summary page 1…Palomar Inc. EsteLux, K020453 McCue Plc. McCue Energist ULTRA, K040659 DDD AIS, Ellipse I2PL, K(060516 System Description: The Cosmnefight Intense Pulsed Light System is comprised of the following main comp… | 2006 |
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 15 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 69 ancestors have a recall of any class.
- 20 other devices also cite its predicate K020839.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Cosinelight Intense Pulsed Light System (and its accessories) are indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow: L. Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the treatment of inflammatory acne. 2. Intense Pulse Light Energy Wavelengths from 560 - 1200…
Read the full statement (141 words)
The Cosinelight Intense Pulsed Light System (and its accessories) are indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow:
L. Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the treatment of inflammatory acne.
2. Intense Pulse Light Energy Wavelengths from 560 - 1200 mnn are indicated for the treatment of benign pigmented (epidermal and oetaneous) lesions Including warts, scars and striae. For the treatment of benign (cutaneous) vascular lesions including port wine stains, hemangiomas, faeial truncal and leg telangiectaslas, rosacea, melasmna, angiomas and spider angiormas, polkiloderma of civatte, leg veins, facial veins and venous realformations.
3. Intense Pulse Light Energy Wavelengths from 700 - 1200 nm are Indicated for the treatment of unwanted hair (i.e., hair removal).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061720: Cosmelight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061720
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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