510(k) · Cleared
ClearedCutera Optional Pulsed Light Hand Piece Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cutera, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 31, 2005 as substantially equivalent to K033549 (Palomar Medical Products, Inc., 2004) and 3 other predicates after an 80-day review. Its family tree reaches back 8 generations to 1992. 109 later devices descend from it.
- Decided
- Mar 31, 2005
- Review
- 80 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K910422 (1992). 66 ancestors in all, the oldest K892514 (1990). 109 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 4 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 3 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 2 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 1 generation backK032460 Profile BBL SystemSciton, Inc · 2003
- This deviceK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- Descendant · cites it directly · 57 of its ownK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- Descendant · cites it directly · 56 of its ownK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- Descendant · cites it directly · 36 of its ownK060407 Juniper Cooling DeviceJuniper Medical Technology, Inc. · 2006
- Descendant · 2 generations on · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
- Descendant · 2 generations on · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008 · cites it directly57descendants
- K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011 · cites it directly56descendants
- K060407Juniper Cooling DeviceJuniper Medical Technology, Inc. · 2006 · cites it directly36descendants
- K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · 2 generations on35descendants
- K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −7 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −5 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −4 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −3 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −2 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −1 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| 0 (this device) | K050047 | Cutera Optional Pulsed Light Hand Piece Family | Cutera, Inc. | 2005 | — |
| +1 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| +1 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| +1 | K060407 | Juniper Cooling Device | Juniper Medical Technology, Inc. | 2006 | — |
| +2 | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
| +2 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, 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 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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? (5)
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 |
|---|---|---|---|
| * | K033549 | Starlux Pulsed Light SystemSummary page 1…Laser Powered Surgical Instrument (and Accessories) III. Predicate Devices * Starlux/Estelux pulsed light hand pieces manufactured by Palomar (K033549, K04008 1, K02094 1) * Profile BBL manufactured by Sciton (K032460) * PRIMA Pulsed Light Th… | 2004 |
| * | K040081 | Palomar Luxv HandpieceSummary page 1…Surgical Instrument (and Accessories) III. Predicate Devices * Starlux/Estelux pulsed light hand pieces manufactured by Palomar (K033549, K04008 1, K02094 1) * Profile BBL manufactured by Sciton (K032460) * PRIMA Pulsed Light Therapy System manufacture… | 2004 |
| * | K020941 | Palomar Luxg HandpieceSummary page 1…nstrument (and Accessories) III. Predicate Devices * Starlux/Estelux pulsed light hand pieces manufactured by Palomar (K033549, K04008 1, K02094 1) * Profile BBL manufactured by Sciton (K032460) * PRIMA Pulsed Light Therapy System manufactured by CoolT… | 2002 |
| * | K032460 | Profile BBL SystemSummary page 1…* Starlux/Estelux pulsed light hand pieces manufactured by Palomar (K033549, K04008 1, K02094 1) * Profile BBL manufactured by Sciton (K032460) * PRIMA Pulsed Light Therapy System manufactured by CoolTouch. IV. Product Description The pulsed lig… | 2003 |
| * | — | PRIMA Pulsed Light Therapy System manufactured by CoolTouch Named without a submission number |
What descends from it? (109)
See all 1095 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 66 ancestors has a recall of any class.
- Of its descendants, K082876 (Sharplight Technologies, Ltd., 2008) has gone furthest, with 57 descendants of its own.
- 11 other devices also cite its predicate K033549.
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 Cutera Optional Pulsed Light Hand Piece Family is indicated for use in the surgical, aesthetic and cosmetic applications requiring selective photothermolysis in the medical specialties of general and plastic surgery and dermatology. The Cutera Optional Pulsed Light Hand Piece Family is intended for the treatment of: * Tattoos; * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); * Cutaneous lesions…
Read the full statement (132 words)
The Cutera Optional Pulsed Light Hand Piece Family is indicated for use in the surgical, aesthetic and cosmetic applications requiring selective photothermolysis in the medical specialties of general and plastic surgery and dermatology.
The Cutera Optional Pulsed Light Hand Piece Family is intended for the treatment of:
* Tattoos;
* Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
* Cutaneous lesions including warts, scars and striae;
* Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, roasacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
* Psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis;
* Removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and
* Mild to moderate inflammatory acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050047 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050047: Cutera Optional Pulsed Light Hand Piece Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050047
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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