510(k) · Cleared
ClearedFocus Medical Naturalase LP and Naturalight Family of Products
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Medical, LLC · GEX Powered Laser Surgical Instrument
Cleared on Sep 7, 2004 as substantially equivalent to K033549 (Palomar Medical Products, Inc., 2004) and 3 other predicates after a 62-day review. Its family tree reaches back 8 generations to 1992. 4 later devices descend from it.
- Decided
- Sep 7, 2004
- Review
- 62 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K910422 (1992). 101 ancestors in all, the oldest K820106 (1982). 4 later devices descend from it, 1 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 backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 2 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 1 generation backK031828 Naturalase LP ND:Yag LaserFocus Medical, LLC · 2003
- This deviceK041829 Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC · 2004
- Descendant · cites it directly · 3 of its ownK081219 Apollo Mini Ipl SystemSandstone Medical Technologies, LLC · 2008
- Descendant · 2 generations on · 2 of its ownK110304 Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011
- Descendant · 3 generations on · 1 of its ownK123777 Multilaser SystemUltralight Laser Technologies, LLC · 2013
- Descendant · 4 generations on · 0 of its ownK233143 PiXel8-RevealRohrer Aesthetics · 2024
Most influential descendants
Showing 4 of 4 · See all- K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC · 2008 · cites it directly3descendants
- K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011 · 2 generations on2descendants
- K123777Multilaser SystemUltralight Laser Technologies, LLC · 2013 · 3 generations on1descendant
- K233143PiXel8-RevealRohrer Aesthetics · 2024 · 4 generations on0descendants
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 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −3 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −2 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| −1 | K031828 | Naturalase LP ND:Yag Laser | Focus Medical, LLC | 2003 | — |
| 0 (this device) | K041829 | Focus Medical Naturalase LP and Naturalight Family of Products | Focus Medical, LLC | 2004 | — |
| +1 | K081219 | Apollo Mini Ipl System | Sandstone Medical Technologies, LLC | 2008 | — |
| +2 | K110304 | Apex ER. Yag / Ipl System | Sandstone Medical Technologies, LLC | 2011 | — |
| +3 | K123777 | Multilaser System | Ultralight Laser Technologies, LLC | 2013 | — |
| +4 | K233143 | PiXel8-Reveal | Rohrer Aesthetics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 10 | 0 |
| 2002 | 13 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K033549 | Starlux Pulsed Light SystemSummary page 1…neral and plastic surgery and in dermatology. Class ILmedical device 21CFR 878.4810 Product Code: GEX Panel: 79 Predicate devices: Palomar Starlux Pulsed Light System (K033549) Lunieiis Family of Intense Pulsed Light (LPL) and IPL/Nd:YAG Laser Systems (K030527) Luumenis WPI, Quanturn Family of Products (… | 2004 |
| * | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsSummary page 1…Product Code: GEX Panel: 79 Predicate devices: Palomar Starlux Pulsed Light System (K033549) Lunieiis Family of Intense Pulsed Light (LPL) and IPL/Nd:YAG Laser Systems (K030527) Luumenis WPI, Quanturn Family of Products (K020839) Focus Medical NaturaLase LP (K031828)… | 2003 |
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…mar Starlux Pulsed Light System (K033549) Lunieiis Family of Intense Pulsed Light (LPL) and IPL/Nd:YAG Laser Systems (K030527) Luumenis WPI, Quanturn Family of Products (K020839) Focus Medical NaturaLase LP (K031828) Page 101 of 104 Natura… | 2002 |
| * | K031828 | Naturalase LP ND:Yag LaserSummary page 1…49) Lunieiis Family of Intense Pulsed Light (LPL) and IPL/Nd:YAG Laser Systems (K030527) Luumenis WPI, Quanturn Family of Products (K020839) Focus Medical NaturaLase LP (K031828) Page 101 of 104 NaturaLase LP and NaturaLight Family of Prod… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081219 | Apollo Mini Ipl System | 2008 | 3 |
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 5 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 101 ancestors have a recall of any class.
- Of its descendants, K081219 (Sandstone Medical Technologies, LLC, 2008) has gone furthest, with 3 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?
NaturaLight IPL System (intense pulsed light) is indicated for: The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait. treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins. NaturaLase LP Indications For Use The Focus Medical…
Read the full statement (719 words)
NaturaLight IPL System (intense pulsed light) is indicated for:
The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait. treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
NaturaLase LP Indications For Use
The Focus Medical NaturaLase LP Laser System and the NaturaLase LP+ System when used in Laser Mode is indicated for:
General Surgical Applications:
Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.
Dermatology/Plastic Surgery:
Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), caf6 au lait macules, seborrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The NaturaLase LP Laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery.
The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles.
The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tern, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
The NaturaLase LP Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick I - VI) including tanned skin.
EndoscopiclLaparoscopic Surgery:
The NaturaLase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied.
Gastroenterology:
Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastrointestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, and hemorrhoids.
General Surgery:
Incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.
Gynecology:
Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum.
Head and NecklOtorhinolaryngology (ENT):
Tissue incision, excision, ablation, and vessel hemostasis.
Hemostasis During Surgery:
Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.
Neurosurgery:
Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma.
Oculoplastics:
Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents.
Orthopedics:
Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.
Pulmonary Surgery:
Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.
Thoracic Surgery:
Cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).
Urology:
All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041829 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041829: Focus Medical Naturalase LP and Naturalight Family of Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041829
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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