Fotona Dynamis Fractional Laser Policy & Procedure Manual

Published:

October 21, 2025

This manual provides the end-to-end governance, safety and clinical workflow for fractional laser treatments using the Fotona Dynamis platform (non-ablative FRAC3® Nd:YAG 1064 nm and ablative fractional Er:YAG 2940 nm). It aligns with Australian regulation, laser safety and infection-control standards, and is intended for clinical practice, audit readiness and patient safety.1 2 3 4 5 6

1. Purpose & Scope

Standardise safe, evidence-based delivery of fractional laser for texture, dyschromia, scars and photodamage; define responsibilities, training, safety controls, and documentation requirements across all NCD staff involved in assessment, treatment and aftercare.1 3 6

2. Regulatory Framework & Governance

Comply with AHPRA cosmetic procedure standards (consent, advertising, minors), NHMRC/ACSQHC infection-control and reprocessing, ARPANSA/Safe Work laser safety and AS/NZS IEC 60825 series, and TGA ARTG/adverse-event obligations; adopt NSW Health laser policy exemplars.1 2 3 7 8 6 9 10 11 10 12 13

3. Device Overview – Fotona Dynamis

Platform combines Nd:YAG 1064 (non-ablative FRAC3®/fractional) and Er:YAG 2940 (ablative fractional). Operators must adhere to IFU, maintain competency sign-off, and document software version and servicing.13 14

4. Roles, Responsibilities & Competency

Treating doctor prescribes parameters, confirms indication/contraindications, leads escalation; operators hold recognised laser-safety training and device competency; LSO oversees room risk controls, signage, eyewear OD logs, plume strategy, and annual audits.1 6 8 12

5. Patient Selection & Risk Stratification

Indications include acne/atrophic scars, rhytides, dyschromia and texture irregularity. Manage PIH risk in Fitzpatrick III–VI with conservative parameters, longer intervals and strict photoprotection; evaluate keloid tendency and psychosocial suitability under AHPRA consent safeguards.1 3 13 14

6. Contraindications (Absolute / Relative)

Absolute: active site infection, suspicious/active skin cancer, recent isotretinoin, inability to protect eyes; Relative: keloid tendency, photosensitising drugs, uncontrolled diabetes, immunosuppression, recent peels/microneedling, dermatitis/rosacea flares, recent UV exposure.3 13 14

7. Pre-Treatment Requirements (T-14 → Day 0)

Education on mechanism, alternatives, expected sessions and downtime; cease retinoids/AHAs/BHAs 5–7 days pre; strict sun avoidance and SPF 50+; review medications and consider HSV prophylaxis; patch test in higher-risk phototypes/scar-prone skin; standardised photography; obtain AHPRA-compliant consent with written aftercare.1 2 3 4 13

8. Treatment-Day Safety Setup

Verify identity/site and consent; enforce controlled area (signage, interlocks, doors), beam-path management, eyewear matched to wavelength/OD, and plume evacuation; cleanse/degrease skin; apply topical anaesthetic for ablative fractional; perform test spot where indicated.3 6 8 12 13

9. Parameter Framework & Technique – Non-ablative FRAC3®

  • Indications: texture, pores, early scars, photodamage.
  • Technique: 2–3 passes with ~10–20% overlap to uniform mild erythema; avoid excessive stacking; air cooling as needed; document wavelength, spot, energy/fluence, pulse width, density, passes, zones, endpoints.6 13

10. Parameter Framework & Technique – Ablative Fractional Er:YAG

  • Indications: scars, deeper rhytides, significant photodamage.
  • Technique: select ablation depth and coagulation per indication; uniform micro-ablation with conservative stacking; maintain plume capture at source; avoid char/blistering; record all parameters and endpoints.6 14

11. Intra-Procedure Monitoring & Stop Criteria

Monitor patient comfort, erythema pattern, plume performance, eyewear compliance and access control. Stop for whitening/blistering, device fault, eyewear breach, plume failure, severe pain or visual symptoms; cool area, review and document incident.6 8 12

12. Immediate Post-Procedure

Apply cool air/compress; bland occlusive for ablative fractional until re-epithelialised; avoid makeup day 0; commence SPF when intact; provide written aftercare and 24/7 contact; schedule review at 2–7 days and 4–6 weeks.3 4 14

13. Aftercare, Downtime & PIH Prevention

Non-ablative: erythema/oedema 24–72 h; subtle texture change 3–7 d.

Ablative: oozing/erythema 24–48 h; crusting 3–7 d; pinkness up to 2–4 w. Cleanse with cool water; petrolatum until healed; no sauna/steam/swimming until intact; SPF 50+ daily; reintroduce actives after healing; mitigate PIH with strict photoprotection and clinician-directed topicals.3 4 13 14 15

14. Red Flags & Urgent Escalation

Rapidly worsening pain, spreading erythema, purulent discharge, fever/chills; vesicular rash (HSV); blistering/necrosis; severe oedema impacting vision; sudden visual symptoms; no improvement after 72 h. Escalate to treating doctor; consider swab, antivirals/antibiotics, short course topical steroids if inflammatory.3 6 8

15. Complication Recognition & Management

  • Erythema/oedema: cool packs; analgesia; short course topical steroids if inflammatory.
  • PIH/PDH: strict sun avoidance; topical lighteners; delay further sessions.
  • Infection: swab and empiric therapy; HSV: prompt antivirals.
  • Scarring/textural change: silicone gels/sheets; consider referral.
  • Ocular exposure: urgent ophthalmology review; document and assess TGA reportability.3 10 11

16. Informed Consent – Mandatory Elements

Explain indication, mechanism, alternatives, expected sessions, specific risks (erythema/oedema, crusting, PIH/PDH, pigment loss, infection incl. HSV, scarring, burns, rare ocular injury), recovery impact on work/sun/heat, photography/privacy and pricing; minors and advertising rules per AHPRA.1 2

17. Documentation & Photography

Standardised pre/post photos; parameter sheet (wavelength, spot, energy/fluence, pulse width, density/coverage, passes, zones), endpoints, analgesia/cooling, any complications; batch numbers; room checklist; QA/service logs; follow-up outcomes (PROMs).3 6 12 13

18. Cleaning, Disinfection & Sterility

Follow NHMRC/ACSQHC guidance for environmental cleaning, reprocessing, PPE; use single-use items where specified; maintain plume capture; appropriate waste management; staff immunisation/exposure management per local policy.3 4 5 12

19. Training, QA & Incident Reporting

Maintain operator competency logs and CPD; LSO annual audits of signage, eyewear OD, interlocks, emergency stop, plume capture; incident reviews and corrective actions; evaluate for TGA adverse-event reporting and notify device sponsor/TGA where applicable.6 10 11 12

20. Advertising & Ethical Communications

Adhere to AHPRA advertising rules: avoid prohibited testimonials/misleading claims; do not target minors; present risks/benefits fairly; display credentials and fee transparency.1 2

© Newcastle Cosmetic Doctor – This manual is reviewed at least annually or on IFU/regulatory change. It supersedes prior laser protocols.

Sources

  1. AHPRA (2025), New cosmetic procedure guidelines published, Australian Health Practitioner Regulation Agency, viewed 19 October 2025, https://www.ahpra.gov.au/sitecore/content/Dental/News/2025-06-03-New-cosmetic-procedure-guidelines.aspx ↩︎
  2. Medical Board of Australia (AHPRA) (2023–2025), Advertising guidelines for regulated health services, viewed 19 October 2025, https://www.medicalboard.gov.au/Codes-Guidelines-Policies/Guidelines-for-advertising-regulated-health-services.aspx ↩︎
  3. NHMRC & ACSQHC (2019), Australian Guidelines for the Prevention and Control of Infection in Healthcare, viewed 19 October 2025, https://www.nhmrc.gov.au/about-us/publications/australian-guidelines-prevention-and-control-infection-healthcare-2019 ↩︎
  4. ACSQHC (2024), NSQHS Preventing and Controlling Infections Standard – resources & tools, viewed 19 October 2025, https://www.safetyandquality.gov.au/standards/nsqhs-standards/preventing-and-controlling-healthcare-associated-infection-standard ↩︎
  5. ACSQHC (2024), Reprocessing of reusable medical devices in health service organisations, viewed 19 October 2025, https://www.safetyandquality.gov.au/standards/implementing-national-standards/standard-3-resources ↩︎
  6. ARPANSA (n.d.), Lasers – Non-ionising radiation and safety advice, viewed 19 October 2025, https://www.arpansa.gov.au/understanding-radiation/what-is-radiation/non-ionising-radiation/laser ↩︎
  7. ARPANSA (2022), Advice for providers: Lasers, IPL devices and LED phototherapy; references AS/NZS IEC 60825.14:2022, viewed 19 October 2025, https://www.arpansa.gov.au/understanding-radiation/sources-radiation/more-radiation-sources/lasers-and-intense-pulsed-light-1 ↩︎
  8. Safe Work Australia (n.d.), Laser classifications and duties of care, viewed 19 October 2025, https://www.safeworkaustralia.gov.au/safety-topic/hazards/laser-classifications ↩︎
  9. Standards Australia (n.d.), AS/NZS IEC 60825 series – Safety of laser products (overview), viewed 19 October 2025, https://infostore.saiglobal.com/en-au/standards/?search=60825 ↩︎
  10. TGA (2024), Australian Regulatory Guidelines for Medical Devices (ARGMD), viewed 19 October 2025, https://www.tga.gov.au/how-we-regulate/australian-regulatory-guidelines-args/australian-regulatory-guidelines-medical-devices-argmd ↩︎
  11. TGA (2024), Reporting adverse events & problems – medical devices, viewed 19 October 2025, https://www.tga.gov.au/reporting-problems/reporting-adverse-events-and-problems ↩︎
  12. SESLHD (NSW Health) (2024), Laser Safety – Managing the Hazards (SESLHDPR/162) [Policy], viewed 19 October 2025, https://www.seslhd.health.nsw.gov.au/sites/default/files/documents/SESLHDPR%2520162%2520-%2520Laser%2520Safety%2520-%2520Managing%2520the%2520Hazards1.pdf ↩︎
  13. Fotona (2023), Dynamis Platform – Clinical Guide & FRAC3® overview, viewed 19 October 2025, https://www.fotona.com/en/products/1309/dynamis-pro/ ↩︎
  14. Fotona (2023), Skin Resurfacing – Er:YAG fractional treatments, viewed 19 October 2025, https://www.fotona.com/en/treatments/65/skin-resurfacing/ ↩︎
  15. Australian Government Department of Health (2024), Sun protection and UV exposure advice, viewed 19 October 2025, https://www.health.gov.au/health-topics/skin-cancer-prevention/sun-protection ↩︎

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