510(k) Report

510(k) · Cleared

Cleared

Focus Medical Naturalase LP and Naturalight Family of Products

K041829510(k) TraditionalCleared Sep 7, 200462-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 2 other ancestors2002: 13 other ancestors2001: 10 other ancestors2000: 11 other ancestors1999: 5 other ancestors1998: 6 other ancestors1996: 9 other ancestors1995: 7 other ancestors1997: 9 other ancestors1994: 8 other ancestors1993: 5 other ancestors1991: 4 other ancestors1990: 1 other ancestor1988: 1 other ancestor1982: 1 other ancestor2008: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant clearedK910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000×2: 2 generations cleared close together, K014040 (2002), K022226 (2002) K031828 · Naturalase LP ND:Yag Laser · Focus Medical, LLC · 200319801990200020102020
  1. Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
  2. 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
  3. 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
  4. 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
  5. 4 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
  6. 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  7. 2 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
  8. 1 generation backK031828 Naturalase LP ND:Yag LaserFocus Medical, LLC · 2003
  9. This deviceK041829 Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC · 2004
  10. Descendant · cites it directly · 3 of its ownK081219 Apollo Mini Ipl SystemSandstone Medical Technologies, LLC · 2008
  11. Descendant · 2 generations on · 2 of its ownK110304 Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011
  12. Descendant · 3 generations on · 1 of its ownK123777 Multilaser SystemUltralight Laser Technologies, LLC · 2013
  13. 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

GenerationNumberDeviceApplicantDecidedRecalls
−8K910422Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc.1992—
−7K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc.1996—
−6K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc.1997—
−5K974536Photoderm HR SystemEsc Medical Systems, Ltd.1998—
−4K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.2000—
−3K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
−2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…Altus Medical, Inc.2002—
−1K031828Naturalase LP ND:Yag LaserFocus Medical, LLC2003—
0 (this device)K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC2004—
+1K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC2008—
+2K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC2011—
+3K123777Multilaser SystemUltralight Laser Technologies, LLC2013—
+4K233143PiXel8-RevealRohrer Aesthetics2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198810
199010
199140
199350
199480
199570
199690
199790
199860
199950
2000110
2001100
2002130
200320
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201310
202410
FIG. 1 — Lineage of K041829, 1992–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K033549Starlux Pulsed Light System
Summary 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 (…
Palomar Medical Products, Inc.2004—
*K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems
Summary 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)…
Lumenis2003—
*K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL
Summary 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…
Lumenis, Inc.2002—
*K031828Naturalase LP ND:Yag Laser
Summary 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…
Focus Medical, LLC2003—

Also cleared against K033549: 11 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083

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 devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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.

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